Senior Manager, Regulatory Strategy
About The Position
Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully. Job Summary: The Senior Manager, Regulatory Strategy supports the development and execution of regulatory strategies for the company's portfolio of therapeutics in Immunology & Inflammation (I&I). This individual contributes to assigned programs under the guidance of the program team, with primary support for US regulatory activities and involvement in ex-US submissions including EMA filings. Working cross-functionally with Clinical, Medical Affairs, and Program Leadership, this role helps advance products from IND/CTA through BLA/NDA/MAA submission across autoimmune and inflammatory conditions. The ideal candidate brings working knowledge of FDA and global regulatory frameworks, sound regulatory judgment, and the ability to operate with agility in a fast-paced, resource-lean biotech environment.
Requirements
- Bachelor's degree in a life sciences, pharmacy, or related field required; advanced degree (MS, PhD, PharmD) preferred.
- 5 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry with a bachelor's degree, 3-4 years with an advanced master's degree, and/or 2 years with a doctoral degree (PharmD/PhD).
- Experience in I&I or adjacent therapeutic areas (e.g., rare disease, neurology, with immune-mediated components) preferred.
- Experience contributing to IND/CTA filings and NDA, BLA, or MAA submissions preferred.
- Exposure to FDA interactions; familiarity with Type B meeting processes and briefing document preparation is a plus.
- Working understanding of ICH guidelines, 21 CFR Parts 312 and 314/601, and applicable international regulatory frameworks.
- Experience working in an early-to-mid stage biotech; comfort operating in ambiguous, high-growth environments
- Building effective partnerships with flexibility and adaptability.
- Commitment to integrity and working efficiently to achieve key team and business outcomes.
- Helps connect regulatory tactics to broader program and business strategy.
- Builds credibility and working relationships across cross-functional teams.
- Strong written and verbal communication skills; ability to synthesize regulatory information for varied audiences.
Nice To Haves
- Familiarity with Type B meeting processes and briefing document preparation is a plus.
Responsibilities
- Support development and execution of regulatory strategies for assigned I&I programs, consistent with health authority expectations and business objectives.
- Contribute regulatory input to Integrated Development Plans (IDPs) and cross-functional program planning activities.
- Assist in assessing regulatory risk across the product lifecycle and help identify mitigation strategies in alignment with cross-functional partners.
- Support preparation of designation requests (e.g., Breakthrough Therapy, Fast Track, Orphan Drug) as applicable.
- Maintain current awareness of the external regulatory environment, including new guidance documents, legislation, and precedents relevant to the I&I landscape.
- Support preparation and execution of US FDA meetings (Type A, B, C), including meeting requests, briefing packages, meeting minutes, and follow-up correspondence.
- Coordinate planning, preparation, and review of regulatory submissions including INDs/CTAs, orphan drug applications, scientific advice packages, NDA/BLA/MAA filings, annual reports, and amendments.
- Support ex-US regulatory interactions, including EMA scientific advice and CTA filings, ensuring consistency with the overall regulatory strategy.
- Perform other duties and responsibilities as assigned
Benefits
- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule
- A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
