Your tasks and responsibilities
Bayer U.S. LLC seeks an Assistant Director, Regulatory Chemistry Manufacturing and Control to work in Whippany, NJ, and be responsible for developing and implementing the regulatory strategy for Chemistry Manufacturing and Control (CMC) for assigned products in close cooperation with the following: country or regional Regulatory Affairs; Health Authorities, Bayer Product Supply, global CMC, Medical Affairs, Drug Safety, and Marketing.
The primary responsibilities of this role, Assistant Director, Regulatory Chemistry Manufacturing and Control, are to:
- ensuring close alignment of relevant CMC regulatory strategies affecting small molecules, biological and gene therapy products within all therapeutic areas;
- providing final content of CMC submission packages for new product development (IND/CTA, MAA/NDA/BLA) as well as post-approval changes; and
- ensuring early identification and coordination of regulatory issues with potential impact on global development timelines.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- master's degree (or foreign equivalent) in Regulatory Science or related field plus four (4) years in a related role in the pharmaceutical industry.
- three (3) years in a Regulatory Affairs role.
- U.S. IND, NDA/BLA submission process and amendments;
- developing regulatory strategies for small molecules, biologics, including gene therapy products in support of new IND/CTA and/or NDA/BLA applications;
- interacting with the FDA and international regulatory bodies inclusive of pre- and post-approval regulatory matters;
- pharmaceutical manufacturing and/or quality control;
- IND/CTA, MAA/NDA and/or BLA drug development, inclusive of applicable health authority and ICH requirements;
- FDA post-approval change requirements (21 CFR 314.70); and
- antibody compounds and gene therapy products regulations to support IND/CTA and NDA/BLA/MAA applications.