Sr. Director, Regulatory Affairs Consultant (Biologics Reg/Reg CMC)

RegDev, Inc. is seeking a seasoned regulatory affairs professional with strong experience in complex biologics to support our global biotech Summary of Job RegDev, Inc., is a consulting service organization with global clients investigating drugs, biologics, devices or combination products in multiple therapeutic areas. We are searching for seasoned regulatory affairs consultants with at least 10-15 years of experience in complex biologics to integrate with clients requiring support e.g., to advise and execute regulatory CMC strategies. Essential Duties and Responsibilities Extensive knowledge of Regulatory Strategy and/or RegCMC biologics development Interpret global regulatory requirements, policies, guidance, and feedback from global health authorities and advise clients on strategic responses and implementation as well as draft responses Develop and execute on regulatory Regulatory and RegCMC strategies Lead preparation, review, and finalization of regulatory and RegCMC documents for US INDs, BLAs, and global CMC applications and responses to agency requests for information Adept at building relationships and collaborating with colleagues and clients Conduct risk assessments, analyze risks, advise on mitigation strategies for clients Proactively remain up to date on regulatory landscape across a variety of biological compound types and formulation delivery systems Work with minimal supervisory oversight, but know when to ask questions internally to ensure solid aligned advice to clients to enable their success

Job Requirements and Education Education/Experience:

Minimum an undergraduate degree (graduate degree preferred) in a scientific discipline Minimum 10 to 15 years' experience in Regulatory CMC Experience preparing, managing, writing, reviewing, advising on US and global biologics Regulatory Strategic and Reg CMC filings Extensive biologics experience Global experience desired

Other Skills and Abilities:

Critical thinker, willing to say "I don't know the answer, but will follow up" and then do so every time Strong, diplomatic, and kind communicator Excellent verbal, written, and soft skills Strong working knowledge of US and OUS requirements Ability to function at a leadership level, including leading discussions, in client facing team settings ADA Notations Ability to sit for long periods of time, handling, feeling with hands, reaching with arms. Regular communication (hearing/speaking). Some travel may be required; overnight travel may be required as needed. Lifting up to 25 lbs. Routine home and potential onsite office duties including computer keyboard use. Vision requirements include close vision and ability to focus. Noise conditions range from quiet to moderate - home office conditions variable.

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