Senior Manager, Regulatory Strategy

About Beeline Medicines:

Beeline Medicines is a clinicalstage 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 companys 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.

Work Arrangement & Location:

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.

Essential Duties and 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:

• Education:Bachelors 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 bachelors degree 3-4 years with an advanced masters 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.

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.

Equal Employment Opportunity:

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity or expression national origin disability age protected veteran status or any other characteristic protected by applicable federal state or local law.

Reasonable Accommodation:

If you require a reasonable accommodation to participate in the application or interview process please contact to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S. Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines