Senior Manager, Regulatory Strategy

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, the Company is developing medicines that have the opportunity to provide durable, life-changing impact.

About the role

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.

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.

Qualifications

• 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.

Schedule

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.

Pay

The expected salary range for this position is $150,000 - $195,000 USD. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Benefits

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

• 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.

Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.