Director/Sr Director, Regulatory Affairs Consultant

Director/Sr Director, Regulatory Affairs Consultant RegDev San Diego, CA Job Details Full-time 1 day ago Qualifications FDA submissions Writing skills Bachelor's degree Regulatory submissions Full Job Description 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. 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.

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