Additional Job Listings

• Location:Houston
• State:TX
• Salary:$130K - $140K
• 

Job Types:

Biotech, Pharma, Med. Device R&D

Associate Director of Regulatory Affairs- Pharmaceutical

The incumbent will be responsible for assisting in the development and implementation of regulatory strategies to facilitate development and obtain timely marketing approval for pharmaceuticals and combination products in the U.S., EU., Japan, and other designated markets; assisting in the development of strategies and advising Manufacturing and QA concerning proposed changes to existing products; maintaining regulatory compliance for existing marketing products; and monitoring changes in the regulatory environment, ensuring such changes are proactively addressed and do not negatively impact the development process and time to approval for new products and supplemental changes.

Minimum Qualifications:

An advanced degree within an appropriate scientific/technical discipline is required. Experience factors are related to prior scientific/technical achievements, background in increasingly responsible management positions of a scientific/technical function, and accomplishments in positions of leadership. Key pieces include:

• Clinical and Pre Clinical experience

• Biologics and/or Ophthalmology

• Pharmaceutical experience

• IND and NDA experience is a must.

(Candidates with a background just in CMC and/or coming from a Medical Device company will not be considered)

Position Success Factors:

Customer Focus; Business Acumen; Planning & Executing; Strategic Thinking; Negotiating; Problem Identification & Resolution; Communication; Teamwork; Results Ownership; Global-Cultural Sensitivity; Courage; Championing Change; Influencing Others; and Fostering Diversity.

Compensation and Benefits:

Salary: 130-140k (commensurate upon experience) 20% bonus, Equity valued at 20k, Matching 401k and top tier Health care coverage.

(437895)