Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
Review, prepare and submit New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), NDA or ANDA amendments and supplements, DMF, NDA or ANDA Annual Reports in accordance with FDA requirements.
Manage FDA and International Submissions for new drug and abbreviated new drug products and product changes to ensure timely approval for market release in accordance with applicable regulations, standards, and guidance.
Maintain regulatory affairs application files to support compliance with requirements and standards. Interact and respond to regulatory agencies. Manages four (4) RA specialist. Reports to a Senior RA Manager.
For detailed JD visit www.pharmaboard.com
Job location: Southwest U.S.
Comp: Six figures, bonus, benefits, relocation
Type: Full-time / Days
Bachelor’s (B.S.) degree in a scientific area of specialty is required.
Minimum 5 years of regulatory related experience with generic and new drug applications and application maintenance with the FDA.
Wide-ranging managerial and leadership skills.
Strong knowledge of NDA, ANDA, MAA, and IND submissions. Working knowledge of cGMPs.
PROTECHPHARMA(R) began operations in New York City in 1984, opened its NJ location in 2010 and the NM office in 2015. We are a nationwide full-service recruiting organization for Technical, Operational and Science positions in Pharmaceutical Manufacturing and R&D Centers. We are committed to honesty and integrity in all our dealings, and to upholding the highest ethical standards in the industry.