Beeline Medicines

Executive Director, Regulatory Affairs

Boston, Massachusetts, United States · Director

Sponsorship not specified$281k-$344kDetected 8 days ago

Clinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationRegulatory 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.
Direct and coordinate the regulatory strategy and execution of assigned projects, including INDs, CTAs, NDAs, MAAs, briefing books, health authority responses, lifecycle management, and indication expansion.
Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies; communicate clear, concise, project updates and recommendations to senior leadership

As a seasoned professional in Regulatory Affairs, develop Global Regulatory strategies and serve as the Global Regulatory Leader (GRL) for assigned Regulatory Project Teams to form global strategies and serve as the US Regulatory Lead (USRL) in the development of US regulatory approaches and execution of US filings
Monitor, interpret, and apply evolving regulations, guidance, and regulatory intelligence to assigned programs while collaborating closely with cross-functional partners to enable successful program outcomes.
Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and collaborate with regulatory authorities; be primary liaison for day-to-day interactions
Perform other duties and responsibilities as assigned.
Lead and oversee regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
Manage regulatory timelines, deliverables, documents, contractors/consultants, and future direct reports, ensuring work is accurate, complete, verifiable, and completed with urgency and accountability.
Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements

Demonstrated track record of leading marketing applications globally, from submission to approval and indication postmarketing maintenance
Experience with investigational drugs, including early and late-stage development, and marketed products
Education: Advanced degree (PhD, PharmD, or master's level) in a relevant life sciences discipline required.
Minimum of 15+ years of Regulatory Affairs experience in pharmaceutical and/or biotechnology industry with at least 5 years as Global Regulatory Lead (GRL)
Hands-on experience with CTA submissions, NDA submissions, MAAs, briefing books, and health authority responses required.
Experience in effective negotiations with FDA and EMA and other global health authorities (e.g., FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
Balances strategic oversight with active involvement in execution and willingness to roll up their sleeves and contribute directly.
Demonstrates an entrepreneurial, self-driven mindset, proactively solving problems and anticipating needs, while exercising strong business acumen to keep leadership appropriately informed and engaged
Proactively identifies issues and drives resolution, using sound judgment to remove obstacles and maintain momentum
Independent but collaborative
able to take ownership without operating as a lone ranger.
Demonstrated ability to coach, mentor, and develop direct reports as well as other members of Regulatory team

$281,000 - $344,000 USD
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.

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.