Associate Director, Regulatory Strategy
Beeline Medicines, Boston, MA, United States
About Beeline Medicines
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. Job Summary
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. 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
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. Qualifications
Education: Bachelor's degree in a life sciences, pharmacy, or related field required; advanced degree (MS, PhD, PharmD) strongly preferred. 7 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry with a bachelor's degree, 5 years with an advanced master's degree and/or 3 years with a doctoral degree (PharmD / PhD). Strong desire to focus 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. Salary Range
The expected annual salary range for this position is $192,000 - $208,500 USD. Actual pay will be determined based on experience, qualifications, location, and other job‑related factors permitted by law. A discretionary annual bonus and long‑term incentive award (e.g., equity) may be available based on individual and Company performance. Benefits
Medical, Dental & Vision insurance (employee premiums 100% covered by company) 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge Flexible work arrangements / hybrid schedule Health Savings Account (HSA) Benefits are subject to eligibility requirements and plan terms. Additional details 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 careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.
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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. Job Summary
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. 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
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. Qualifications
Education: Bachelor's degree in a life sciences, pharmacy, or related field required; advanced degree (MS, PhD, PharmD) strongly preferred. 7 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry with a bachelor's degree, 5 years with an advanced master's degree and/or 3 years with a doctoral degree (PharmD / PhD). Strong desire to focus 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. Salary Range
The expected annual salary range for this position is $192,000 - $208,500 USD. Actual pay will be determined based on experience, qualifications, location, and other job‑related factors permitted by law. A discretionary annual bonus and long‑term incentive award (e.g., equity) may be available based on individual and Company performance. Benefits
Medical, Dental & Vision insurance (employee premiums 100% covered by company) 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge Flexible work arrangements / hybrid schedule Health Savings Account (HSA) Benefits are subject to eligibility requirements and plan terms. Additional details 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 careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.
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