Summary of Job

We are seeking an experienced Director/Sr. Director, Regulatory Affairs Consultant with the potential to transition to full-time employment to support activities for RegDev, Inc’s regulatory team within global multiple therapeutic areas and activities for RegDev clients.

Essential Duties and Responsibilities

• Lead and/or development of regulatory documents for US and OUS submissions, e.g., meeting packages, new INDs, designation requests, PIPs/PSPs.
• Interpret regulatory requirements, policies, guidance, and feedback from global health authorities and advise clients on strategic responses and implementation as well as draft responses.
• Execute on regulatory strategies.
• Review regulatory documents and clinical documents for regulatory submissions.
• Act as regulatory lead or participant on client cross-functional core and working teams.
• Provide strategic regulatory advice and feedback to clients regarding projects and development programs.
• Work closely with subject matter experts to draft regulatory documents.
• Conduct risk assessments, analyze risks, advise on mitigation strategies for clients.
• Proactively remains up to date on regulatory landscape.
• Work with minimal supervisory oversight but know when to ask questions internally in order to ensure solid aligned advice to clients to enable their success.

Job Requirements and Education

Education:

• Minimum bachelor’s degree in life science field, master’s degree preferred.

Experience:

• At least 15+ years’ experience in regulatory affairs.
• Critical thinker, willing to say, “I don’t know the answer, but will follow up” and then do so every time.
• Regulatory lead in clinical programs.
• Experience preparing, managing, writing, and filing NDA/BLA/IND/IMPD/510k/PMA/IDE.
• Global experience preferred.

Other Skills and Abilities: 

• Strong, diplomatic, and kind communicator.
• Excellent verbal and written 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).
• Approximately 10% travel is required, overnight travel required as needed.
• Routine home and 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