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Director- Federal Govt Affairs
Washington, D. C.
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operati...
Last Updated: 05/21/2013
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Manager, Regulatory Affairs
Lake County, Illinois
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based ...
Last Updated: 05/21/2013
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Deputy General Counsel - Regulatory
Northbrook, Illinois
Astellas is announcing a Deputy General Counsel, Regulatory opportunity in our Northbrook, IL location.
Responsible for heading up legal regulatory function in providing practical, ...
Last Updated: 05/21/2013
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SENIOR REGULATORY AFFAIRS SPECIALIST-
Santa Clara, California
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based ...
Last Updated: 05/21/2013
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Assistant General Counsel, Regulatory
Northbrook, Illinois
Astellas is announcing an Assistant General Counsel, Regulatory opportunity in our Northbrook, IL location.
Responsible for providing practical, timely and high quality legal servic...
Last Updated: 05/21/2013
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Assistant Federal Government Affairs Director
Washington, D. C.
Astellas is announcing a Assistant Federal Government Affairs Director opportunity in our Washington, DC location.
Assist in the federal government affairs function for APUS/AUS incl...
Last Updated: 05/21/2013
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Controlled Substances Regulatory Specialist
Lake County, Illinois
The Controlled Substances Regulatory Specialist is responsible for providing guidance on all matters related to the regulatory compliance requirements as mandated by the Drug Enforcement Administra...
Last Updated: 05/21/2013
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Manager, Regulatory Affairs
Teva Pharmaceuticals USA is looking for a Manager, Regulatory Affairs for our Horsham, PA facility. This position will be responsible for the regulatory assessment of change control for appro...
Last Updated: 05/21/2013
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Sr. Associate Regulatory Affairs
Lake County, Illinois
This position is in support of remediation and technology transfer activities for currently marketed products. The Sr. Regulatory Affairs Associate provides regulatory support and expertise b...
Last Updated: 05/21/2013
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Associate Director, Regulatory Affairs CMC
Malvern, Pennsylvania
We are currently seeking an Associate Director for Regulatory Affairs-CMC. The Regulatory Affairs Associate Director for CMC will represent the company’s regulatory group in internal an...
Last Updated: 05/21/2013
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Manager, Regulatory Affairs
Huntsville, Alabama
Manager, RA Commercial Support will be responsible for the regulatory assessment of change control for approved ANDAs and will direct the preparation, review, and approval of submissions to F...
Last Updated: 05/21/2013
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Senior Associate, Regulatory Publishing
Bridgewater, New Jersey
Under limited supervision, electronically prepares documentation that is complete, accurate, on time, and electronically functional. Publishes complex reports under minimal supervision.&n...
Last Updated: 05/21/2013
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Specialist/Sr. Specialist, Regulatory Affairs
Bridgewater, New Jersey
The Specialist / Sr. Specialist, Regulatory Affairs - CMC is responsible for actively contributing in planning for and preparation of regulatory submission documents for US and global regu...
Last Updated: 05/21/2013
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Manager, Regulatory Affairs
Miami, Florida
Ferring Pharmaceuticals is a private, research-driven specialty biopharmaceutical company active in global markets. The company identifies, develops and markets innovative products in the fields of...
Last Updated: 05/21/2013
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Sr. Associate/Specialist, Reg Affairs Operations
New Jersey
The Regulatory Operations Senior Associate/Specialist will support the global extent of e-submissions and use of Insight Publisher and/or Novodocs for regulatory submissions in Novo Nordisk and wil...
Last Updated: 05/21/2013
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Sr Mgr, Reg Affairs
Woodcliff Lake, New Jersey
This position provides regulatory support for an investigational tyrosine-kinase inhibitor. Currently, the compound is being investigated in in 8 different tumours (thyroid cancer, HCC, melanoma, g...
Last Updated: 05/21/2013
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Sr. Manager/Associate Director,Regulatory Affairs - Promotional Review
Princeton, New Jersey
Manage the Regulatory review of Promotions and Advertisements for company marketed products.
RELATIONSHIPS:
Reports to the Director, Promotional Review. Works with other personnel in Mark...
Last Updated: 05/21/2013
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Sr. Manager/Associate Director,Regulatory Affairs - Promotional Review
Princeton, New Jersey
Manage the Regulatory review of Promotions and Advertisements for company marketed products.
RELATIONSHIPS:
Reports to the Director, Promotional Review. Works with other personnel in Mark...
Last Updated: 05/21/2013
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Associate Director-Government Affairs
New Jersey
PURPOSE:
• Conducts the strategic lobbying activities in designated Region, including approximately 12 states. Owns the development, advocacy, communications and execution of key business an...
Last Updated: 05/21/2013
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Director Regulatory Affairs Advertising & Promotion
New Jersey
The Advertising and Promotion Director serves as the regulatory lead for all Pharmaceutical, OTC and Nutritional promotional labeling and advertising materials and serves as the primary interface w...
Last Updated: 05/21/2013
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Sr. Labeling Specialist
New Jersey
The Sr. Regulatory Affairs Labeling Specialist is responsible for managing various projects as they pertain to regulatory labeling functions to ensure compliance with applicable regu...
Last Updated: 05/21/2013
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Regulatory Affairs Specialist
California
The Surgical Regulatory Affairs Specialist is responsible for US and EU registrations for surgical devices as assigned. Products include IOLs, Inserters, OVDs, Equipment, Instruments and S...
Last Updated: 05/21/2013
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Regulatory Affairs Specialist: Operations
California
The Surgical Regulatory Affairs Specialist-Operations is responsible for supporting the Regulatory Affairs operations and process improvement activities under supervision of the Regulatory Affairs ...
Last Updated: 05/21/2013
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Manager Regulatory Affairs Advertising & Promotion
Madison Site, New Jersey
The advertising and promotion regulatory review manager reviews, approves, and monitors product advertising and promotional labeling pieces for compliance with regulatory agencies’ requiremen...
Last Updated: 05/21/2013
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Director, Regulatory Affairs - Advertising and Promotion
Cambridge, Massachusetts
The Director, Advertising and Promotion will be responsible for directing the regulatory aspects of review and approval of promotional materials and marketing activities for applicable Genzyme prod...
Last Updated: 05/21/2013
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Director Reg Affairs
Allston, Massachusetts
Reporting into the Senior Director, Regulatory Compliance and Consent Decree Management, this position will support Regulatory Affairs activities related to the Quality remediation initiatives asso...
Last Updated: 05/21/2013
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Sr Manager, Government Relations
Washington, D. C.
Undergraduate degree required. At least five years experience in one or more of the following fields: Capitol Hill legislative staff, public relations, government relations, political activities, l...
Last Updated: 05/21/2013
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Senior Manager, US Compliance & Training, Regulatory Affairs Job
Berkeley Heights, New Jersey
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 co...
Last Updated: 05/21/2013
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Senior Director, Regulatory Affairs, CCT Job
Warren Township, New Jersey
The role of Senior Director of Regulatory Affairs at Celgene Cellular Therapeutics is of key importance to the continued growth and development of CCT’s clinical, research and manufacturing p...
Last Updated: 05/21/2013
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Sr Manager, Government Relations
Washington, D. C.
Undergraduate degree required. At least five years experience in one or more of the following fields: Capitol Hill legislative staff, public relations, government relations, political activities, l...
Last Updated: 05/21/2013
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Manager, Regulatory Affairs - Chemistry, Manufacturing and Controls
South San Francisco, California
Responsible for coordination, gathering of information, and review of documents for CMC related documents for Regulatory submissions.
Work closely with Regulatory and CMC staff...
Last Updated: 05/21/2013
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Associate Director, Regulatory Affairs
South San Francisco, California
Essential/Primary Duties, Functions and Responsibilities
Develop and implement strategies to facilitate the progress of Phase I through Phase IV development of drugs and biologics.
Re...
Last Updated: 05/21/2013
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Sr Manager, Global Regulatory CMC
Basking Ridge, New Jersey
BS/BA degree in Scientific/Engineering Discipline (Masters or higher is a plus) with 68 years in the pharmaceutical industry, including 35 years CMC regulatory experience
...
Last Updated: 05/21/2013
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Senior Manager, US Compliance & Training, Regulatory Affairs
Berkeley Heights, New Jersey
Prerequisites:
Bachelor or equivalent in scientific discipline, life science
6-8 years Pharmaceutical industry experience including experience in a compliance or regulatory affairs ro...
Last Updated: 05/21/2013
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Senior Director, Regulatory Affairs
Warren Township, New Jersey
Prerequisites:
Advanced scientific discipline degree: 8-12 years pharmaceutical industry experience, with 6-8 in regulatory. MD, PhD or PharmD preferred
SUMMARY:
&...
Last Updated: 05/21/2013
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Manager, Medical Writing
Foster City, California
The Medical Writing function resides organizationally within Regulatory Affairs at Gilead and provides scientific/regulatory writing services to support clinical trial reporting as well as a wide v...
Last Updated: 05/21/2013
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Regulatory Affairs Manager, International
New Jersey
The role of the International Regulatory Affairs Manager is to coordinate with Forest’s local affiliates or local partners and the US project team to prepare and manage the international regu...
Last Updated: 05/21/2013
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Regulatory Affairs Mgr (Product Project Management)
Thousand Oaks, California
GPPM will be Responsible for:
Providing project management support and coordinating achievement of deliverables for global regulatory, global safety, and regulatory CMC subfunction project ...
Last Updated: 05/21/2013
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Regulatory Affairs Mgr (Product Project Management)
Thousand Oaks, California
GPPM will be Responsible for:
Providing project management support and coordinating achievement of deliverables for global regulatory, global safety, and regulatory CMC subfunction project ...
Last Updated: 05/21/2013
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Exec Dir Regulatory Promotion and Material Compliance Functional Head
Thousand Oaks, California
The Global Regulatory Affairs and Safety (GRAAS) US Regulatory organization is looking for an Executive Director, Regulatory Promotion and Material Compliance Functional Head.
This position wi...
Last Updated: 05/21/2013
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Regulatory Writing Mgr
Thousand Oaks, California
This position could be located in Thousand Oaks California, South San Francisco California, or at a remote home office.
Job Summary:
Write, rewrite, and edit and gain senior management ap...
Last Updated: 05/21/2013
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Regulatory Writing Mgr
Thousand Oaks, California
Write, rewrite, and edit and gain senior management approval of scientific and regulatory documents that comply with global regulatory standards.
Serve as functional area lead on product teams. T...
Last Updated: 05/21/2013
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Sr Finance Manager, Regulatory, Quality & Compliance
South San Francisco, California
The Senior Finance Business Partner will support senior leaders in Technical Regulatory and Quality and Compliance (RQC). Quality & Compliance, the broadest Functional Unit of the PT netw...
Last Updated: 05/21/2013
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Associate Director, Technical Regulatory Team Program Management
South San Francisco, California
Technical Regulatory is a global function that supports strategic regulatory and submission activities for the Roche and Genentech product portfolio. Support of individual portfolio projects is man...
Last Updated: 05/21/2013
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Regulatory Affairs Mgr (CMC Systems)
Thousand Oaks, California
The CMC Systems group is responsible for developing, maintaining and improving the practices and procedures used to streamline and coordinate investigational and marketing applications. This group ...
Last Updated: 05/21/2013
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Program Director, Regulatory CNS/Metabolism
South San Francisco, California
Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and presen...
Last Updated: 05/21/2013
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Sr Regulatory Product Manager/Scientist
South San Francisco, California
In the position of Senior Regulatory Product Manager in Technical Regulatory Affairs, you will be accountable for the preparation of regulatory submissions and strategies supporting the product&rsq...
Last Updated: 05/21/2013
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Global Regulatory Leader (Oncology)
South San Francisco, California
Global Regulatory Leader
Accountable for regulatory management of a project(s) and leading a matrix team of regulatory professionals.
Primary Responsibilities and Acco...
Last Updated: 05/21/2013
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Senior Regulatory Product Manager/ Reg. Scientist
South San Francisco, California
The Technical Regulatory Senior Product Manager will be responsible for developing global regulatory strategy, writing high quality dossiers, and leading teams for assigned projects to obtain timel...
Last Updated: 05/21/2013
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Associate Program Director, Regulatory Small Molecule Development
South San Francisco, California
As a product manager, you will be responsible for supporting the preparation, assembly, and review of both product and facility-related Chemistry Manufacturing and Controls (CMC) regulatory submiss...
Last Updated: 05/21/2013
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COUNSEL, COMMERCIAL/REGULATORY (METABOLICS)
Bristol-Myers Squibb is looking for an experienced pharmaceutical attorney to join its U.S. Legal and Promotion Integrity Department. Bristol-Myers Squibb is a global BioPharma company firmly focus...
Last Updated: 05/21/2013
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Associate Director - Global Regulatory Affairs Projects
King of Prussia, Pennsylvania
The position is responsible for overseeing all aspects of the regulatory process for a key global R&D project to ensure efficient and timely registration of products throughout t...
Last Updated: 05/21/2013
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Associate Director, GMP
New Brunswick, New Jersey
Description
As manager of the GMP Quality Unit, lead a team of staff who review and approve lifecycle activities associated with the commissioning, qualification, validation and use ...
Last Updated: 05/21/2013
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Regulatory Affairs Assoc II
Salt Lake City, Utah
Under general supervision, performs routine dutiesin the preparation, review and submission of pre-and post-approval submissions to the Food and Drug Administration, using governmental guidelines a...
Last Updated: 05/21/2013
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Senior Documentation Specialist, Regulatory Affairs
Morgantown, West Virginia
We currently recruiting for a Senior Documentation Specialist in our Regulatory Affairs department located at our facility in Morgantown, WV. The candidate selected will be responsible for ov...
Last Updated: 05/21/2013
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Director, Regulatory Affairs
Morgantown, West Virginia
We are currently seeking a Director, Regulatory Affairs for our Morgantown, WV location. This person will conduct thorough reviews and manage the preparation of new Abbreviated New Drug Application...
Last Updated: 05/21/2013
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Associate Manager, Regulatory Change Control
Morgantown, West Virginia
The Associate Manager, Regulatory Change Control will be responsible for Regulatory interface for the Quality Control Laboratory. Must effectively manage the change control of analytical meth...
Last Updated: 05/21/2013
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Senior Specialist, Regulatory Affairs
Morgantown, West Virginia
Responsible for the compilation and preparation of regulatory submissions for parenteral pharmaceutical products primarily to the US market.
Perform job functions in accordance with ...
Last Updated: 05/21/2013
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Associate Director, Regulatory Affairs Strategy
Cambridge, Massachusetts
The Associate Director is responsible for developing and implementing innovative global regulatory strategies in support of various departments, projects, and subteams. In addition, the Associate D...
Last Updated: 05/21/2013
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Director, Regulatory Compliance Recovery Program Management
New Brunswick, New Jersey
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for ...
Last Updated: 05/21/2013
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Director, Regulatory Compliance Recovery Program Management
New Brunswick, New Jersey
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for ...
Last Updated: 05/21/2013
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Associate Director, Global Regulatory Established Products
Deerfield, Illinois
OBJECTIVES:
Oversees as well as executed all regulatory activities of multiple projects including one highly complex project for assigned marketed product(s) of responsibility....
Last Updated: 05/21/2013
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Director, Regulatory Affairs, Promotion and Advertising
Deerfield, Illinois
OBJECTIVE:
Leads review, submission and execution of advertising and promotional items for Takeda Pharmaceuticals USA across 3 or more therapeutic areas. Serves as back-up to F...
Last Updated: 05/21/2013
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Global Regulatory Affairs Therapeutic Area Head (Neuroscience)
Deerfield, Illinois
OBJECTIVE:
Provides global regulatory oversight for assigned therapeutic area (s), focused on non-clinical and clinical aspects of drug development and associated regulations.
...
Last Updated: 05/21/2013
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Global Regulatory Communication Management Manager
Deerfield, Illinois
OBJECTIVES:
The department Global Regulatory Communication Management (BCM) creates or supports the creation and distribution of internal communication and information ...
Last Updated: 05/21/2013
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Manager, Regulatory Affairs Strategy
Deerfield, Illinois
OBJECTIVES:
Plans/manage/executes all regulatory activities of all levels of complexity for project of responsibility in development and/or supports regulatory activities for assigned marke...
Last Updated: 05/21/2013
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Manager, Regulatory Affairs
Huntsville, Alabama
All businesses; Evaluate change controls and provide final regulatory assessment. Review ANDAs, Amendments, Supplements, Annual Reports, Control Documents, etc. for FDA submissions.&nbs...
Last Updated: 05/21/2013
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Manager, Regulatory Strategy
Deerfield, Illinois
Description
OBJECTIVES:
Plans/manage/executes all regulatory activities of all levels of complexity for project of responsibility in development and/or supports regulatory activities fo...
Last Updated: 05/21/2013
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Manager, Regulatory Strategy
Deerfield, Illinois
OBJECTIVES:
The Manager of Regulatory Strategy-CMC (Chemistry, Manufacturing, and Controls) is responsible for supporting the overall CMC strategy. This position is responsible for the revi...
Last Updated: 05/21/2013
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CMC Regulatory Project Manager / Manager / Director
Research Triangle Park, North Carolina
Basic qualifications:
BSc in pharmacy, chemistry or related scientific discipline or equivalent qualification.
CMC regulatory affairs or product development experience gained with inv...
Last Updated: 05/21/2013
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Manager, Labeling Strategy
Philadelphia, Pennsylvania
Basic qualifications:
Bachelor of Science in Health care or Pharmacy
Great attention to detail.
Excellent interpersonal, writing and oral communication sk...
Last Updated: 05/21/2013
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OPtimuM Effectiveness Lead
Research Triangle Park, North Carolina
Basic qualifications:
*****THERE ARE TWO POSITIONS*****
Bachelor's degree
7-10 years broad based experience in Pharmaceutical R&D...
Last Updated: 05/21/2013
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North America Lead, Clinical Regulatory Immunotherapeutics
King of Prussia, Pennsylvania
Basic qualifications:
BA or BS in science
5-7 years regulatory experience in development and life-cycle management; including supervisory and project management experience...
Last Updated: 05/21/2013
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Director, Regulatory Advertising and Promotion Policy
Philadelphia, Pennsylvania
Basic qualifications:
Degree in a biological or health care scientific discipline
5 -7 years of experience in pharmaceutical/biologics regulatory, or scientific disci...
Last Updated: 05/21/2013
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Senior Manager Commercial Compliance
Rockaway, New Jersey
The Senior Manager Commercial Compliance will play a leadership role in developing and implementing methodologies to monitor sales and marketing promotional activities. This role will help ensure t...
Last Updated: 05/21/2013
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Oncology Project Manager
Cambridge, Massachusetts
Foster drug development by facilitating identification and resolution of scientific and regulatory issues with the regulatory agencies. Responsible for or contribute in formulating the worldwide pr...
Last Updated: 05/21/2013
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Oncology GRA Global Head
Cambridge, Massachusetts
Part of the RD team, and is responsible and accountable for final decisions for the fulfilment of the mission and goals of the US Regulatory Development group and 2 global therapeutic axis (Oncolog...
Last Updated: 05/21/2013
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Director - Associate Director - Regulatory Affairs - Biologics - Small Molecule – Biotech
Wayne, Pennsylvania
Our client has asked us to assist them in filling a full time Director or Associate Director of Regulatory Affairs, Biologics or Small Molecule.
You will provide globa...
Last Updated: 05/21/2013
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Senior Director - Director - Regulatory Affairs
Horsham, Pennsylvania
SENIOR DIRECTOR or DIRECTOR REGULATORY AFFAIRS
Medical Device experience and Commerical experience in Regulatory (publications, etc). Ideally candidate will have EU regulations as w...
Last Updated: 05/21/2013
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