Regulatory Affairs Strategist
1 week ago
We are seeking an experienced Director, Regulatory Affairs to join our team at Umoja Biopharma. The successful candidate will have a minimum of 10 years of experience in regulatory affairs, with a focus on regulatory documentation and lifecycle management within the pharmaceutical or biotechnology industry.
The ideal candidate will have expertise in regulatory requirements across development stages and post-approval, including biologics and small molecules. Experience with oncology products and combination products is desired. The role requires strong strategic and analytical abilities, diplomacy, and negotiation skills, as well as the ability to collaborate across multiple functions.
Key Responsibilities:
- Provide effective phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for development projects.
- Plan, prepare, and manage submissions to Health Authorities (HAs), including DMFs, INDs, NDA/BLA, and CTD regulatory filings.
- Lead regulatory interactions with HAs, including managing preparation of briefing materials for HA meetings, preparing subject matter experts (SMEs), and ensuring appropriate follow-up.
Requirements:
- BS/BA degree (or equivalent) in a relevant scientific field required; advanced degree (MS or PhD) preferred.
- A minimum of 10 years of experience in regulatory affairs, with a focus on regulatory documentation and lifecycle management within the pharmaceutical or biotechnology industry.
Salary Range: $195,500 - $237,000 per year.
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