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.

EQUAL OPPORTUNITY EMPLOYER