Beeline Medicines

Associate Director, Regulatory Strategy

Boston, Massachusetts, United States · Director

Sponsorship not specified$192k-$209kDetected 20 days ago

ComplianceProduct ManagementFDA RegulatoryLeadershipCommunicationBiostatisticsRegulatory Affairs

About the role

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.
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.
Lead preparation and execution of US FDA meetings (Type A, B, C), including meeting requests, briefing packages, meeting minutes, and follow-up correspondence.
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.
Perform other duties and responsibilities as assigned

ability to synthesize complex regulatory information for varied audiences.
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

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
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

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired.
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.
$192,000 - $208,500 USD
Equal Employment Opportunity:
We celebrate diversity and are committed to creating an inclusive environment for all employees.

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices.
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
Specific benefit details applicable to your country or region will be provided during the offer process.
Benefits may include, but are not limited to:
Flexible work arrangements / hybrid schedule
Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms.

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.

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation.
We are committed to providing equal access to all candidates.
Beeline Medicines is an Equal Opportunity Employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees.

This listing is sourced directly from Beeline Medicines's careers page and normalized into a canonical job model.