Senior Manager, Regulatory Strategy

About Beeline Medicines:

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.

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.

Hybrid
- This position follows a hybrid work schedule, requiring a minimum of two (2) days on‑site per week — currently designated as Tuesday and Wednesday. Additional on‑site days may be required based on business needs, team priorities, or leadership direction.

• 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

• Education:
  
  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…