Associate Director, Regulatory Strategy

Beeline Medicines•Boston, MA

2d•Hybrid

About The Position

The Associate Director, Regulatory Strategy is a key member of the Regulatory Affairs organization, responsible for developing and implementing regulatory strategies for the company's portfolio of therapeutics in Immunology & Inflammation (I&I). This individual will serve as the regulatory lead for assigned programs, with primary accountability for US regulatory activities and meaningful involvement in ex-US strategies including EMA and other international health authorities. Working cross-functionally with Clinical, Medical Affairs, and Program Leadership, this role guides products from IND/CTA through BLA/NDA/MAA submission across autoimmune and inflammatory conditions including but not limited to lupus, rheumatoid arthritis, inflammatory bowel disease, and atopic dermatitis. The ideal candidate brings deep 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
7 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry with bachelors degree, 5 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry with Advance Masters Degree and/or 3 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry with doctoral degree (PharmD / Ph.D).
Strong desire of focused on regulatory strategy preferred.
Demonstrated experience in I&I or adjacent therapeutic areas (e.g., rare disease, neurology, with immune-mediated components).
Direct experience authoring or contributing to IND/CTA filings and NDA, BLA, or MAA submissions preferred.
Experience interacting with FDA; familiarity with Type B meeting processes and briefing document preparation.
Strong understanding of ICH guidelines, 21 CFR Parts 312 and 314/601, and applicable international regulatory frameworks.
Experience with biologics (mAbs, fusion proteins, or other large molecules) in an I&I indication.
Familiarity with EMA regulatory processes, scientific advice procedures, and CTA requirements.
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.
Excellent written and verbal communication skills; ability to synthesize complex regulatory information for varied audiences.

Nice To Haves

advanced degree (MS, PhD, PharmD) strongly preferred

Responsibilities

Develop and implement regulatory strategies for assigned I&I programs, consistent with health authority expectations and business objectives.
Provide strategic regulatory input to Integrated Development Plans (IDPs) and cross-functional program planning activities.
Assess regulatory risk across the product lifecycle and ensure mitigation strategies are identified and aligned with cross-functional partners.
Identify optimal regulatory pathways and lead 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.
Translate health authority feedback and regulatory intelligence into actionable program strategies, communicating implications clearly to program teams and senior leadership.
Lead preparation and execution of US FDA meetings (Type A, B, C), including meeting requests, briefing packages, meeting minutes, and follow-up correspondence.
Oversee planning, preparation, and review of high-quality regulatory submissions including INDs/CTAs, orphan drug applications, scientific advice packages, NDA/BLA/MAA filings, annual reports, and amendments.
Serve as primary regulatory contact for assigned programs with US FDA; coordinate ex-US regulatory activities with regional leads or CROs as appropriate.
Support ex-US regulatory interactions, including EMA scientific advice and CTA filings, ensuring consistency with the overall regulatory strategy.
Serve as the regulatory representative on cross-functional program teams, ensuring alignment on critical regulatory issues, risks, and timelines.
Communicate regulatory requirements, risks, and opportunities clearly and proactively to non-regulatory stakeholders including Clinical, Biostatistics, and Medical Affairs.
Partner with Medical Writing to ensure regulatory compliance and quality across submission documents.
Perform other duties and responsibilities as assigned