Associate Director, Regulatory Strategy - I&I
Beeline Medicines
Beeline Medicines seeks an Associate Director for Regulatory Strategy to guide regulatory requirements for therapeutics in Immunology and Inflammation. The role includes developing strategies and overseeing submissions to health authorities. A minimum of 7 years of regulatory experience in the biopharmaceutical industry is required, as well as strong knowledge of FDA processes. This position offers a hybrid work schedule. #J-18808-Ljbffr Beeline Medicines
$192k - $208.5k
...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...SuggestedLocal area2 days per week$190k - $215k
...Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal... ...about this opportunity as we are! Your Impact As Associate Director, Regulatory Strategy, you'll help define the regulatory path for our small-molecule...SuggestedFull timeWork at officeLocal areaImmediate start- A leading biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires extensive experience in regulatory affairs, particularly in oncology, to ensure alignment between US and...Suggested
- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of Moderna’s US offices. This role is for a forward‑looking, creative and agile regulatory strategist able to anticipate and address...Suggested
- Zenith LifeScience is seeking a Clinical Regulatory Writing Associate Director to manage clinical regulatory writing activities across complex projects. You will author critical clinical-regulatory documents and provide strategic communication leadership. The ideal candidate...Suggested
$170k - $220k
...Associate Director, Regulatory CMC – Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision genetic medicine company focused on advancing... ...program teams and bridges CMC development and regulatory strategy. We are seeking an Associate Director of Regulatory...Full timeTemporary workRemote workFlexible hours$95k - $135k
...different stages of maturity. Some are the industry standard, some are starting off. There is a lot to learn, there is room to grow. Our Strategy function is responsible for the success of our products in the market; that’s from guiding the product to client success. Today,...Work experience placementWork at officeLocal areaWork from homeFlexible hours- ...Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies... ...taking leadership roles in professional associations, industry, and trade groups as appropriate...Worldwide
$196.7k - $353.4k
...The role Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first‑in‑class therapeutics and drive successful global development and...Permanent employment$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA- Remote Position Summary The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support successful clinical...Temporary workLocal areaRemote workWeekend work$180k - $210k
...the focus of every strategic decision. Role Summary The Associate Director, US Corporate Strategy reports directly to the Director, Head of US Corporate... ...oncology or rare disease markets, drug development, regulatory processes, and commercial and market access dynamics preferred...Full timeContract workTemporary workWork experience placementFlexible hours- A global pharmaceutical company is seeking a Director of Regulatory Affairs to lead the development and implementation of global regulatory strategies for products in Boston. The ideal candidate will have over 5 years of regulatory experience, specifically in a strategic...
- CVS Health is seeking a seasoned professional to join the Network Strategy and Provider Experience team, ensuring compliance and regulatory readiness. The role will involve leading engagements across compliance and regulatory affairs, analyzing requirements, and managing...Work at office
$183.55k - $275.32k
Director/Sr. Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory Who we are: At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections...Temporary workLocal areaRemote workWork from homeFlexible hours3 days per week- Vertex Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Senior Director to lead the development of regulatory strategies for complex projects. This central role is based in Boston and involves overseeing regulatory submissions and communications. The successful...
- AstraZeneca GmbH in Boston, MA is seeking a Director of Regulatory Affairs Strategy for Cell Therapy to lead global regulatory strategy across oncology, immune-mediated and rare diseases. You will drive Health Authority engagements, submissions, and labeling, mentor cross...
$185.6k - $278.4k
General Summary The Regulatory Labeling Director will lead the strategic development of global labeling... ...governance requirements and associated business processes. Leads label working... ...markets (US, EU, GB, CA). Leads labeling strategy with expert ability to advise...Remote jobFull timeLocal area2 days per week$190k - $240k
Location: Boston, US (hybrid) Reporting to: Executive Director, Regulatory Science Orchard Therapeutics, a Kyowa Kirin company, is a global... ...which is responsible for the development of global regulatory strategy and execution of regulatory activities for ex‑vivo Gene...Odd jobLocal area$185k - $197k
Job Description Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Associate Director, Regulatory Affairs, Advertising and Promotion... ...(written and verbal). Ability to shape strategies based on emerging trends. Ability to communicate...Work at officeLocal areaFlexible hours3 days per week$186.23k - $279.35k
Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MD Boston, MA South San Francisco, CA Santa Monica, CA Introduction to Role Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care...Hourly payTemporary workLocal areaFlexible hours- Green Key Resources seeks an Associate Director of Regulatory Advertising/Promotion in Boston, MA. This hybrid role involves overseeing regulatory advice for assigned products and collaborating with various departments to ensure compliance with FDA regulations. The ideal...
$189k - $246k
Travere Therapeutics, located in Boston, is seeking a Director of Regulatory Affairs Strategy. The role involves developing and executing global regulatory strategies for Phase 2 and Phase 3 drug development programs. As the regulatory lead, you will ensure compliance,...Remote job$187.5k - $275k
...editing medicines for serious diseases. Regulatory affairs collaborates cross functionally... ...in building successful regulatory strategies. Verve is located in Boston, just down... ...Fenway Park. Responsibilities The Senior Director, Regulatory Affairs is responsible for...Full timeWork at officeFlexible hours3 days per week$232k - $348k
Job Description The Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy... .../agency regulatory meeting, committees and trade associations. Remains up to date on changing regulations, and regulatory...Summer workLocal areaRemote workFlexible hours2 days per week3 days per week$210k - $235k
Vor Bio is looking for a Director of Regulatory Strategy in Boston, MA. This role involves global leadership in regulatory strategy for developmental programs in immunology. The Director will work closely with cross-functional teams to ensure compliance and effectively...Remote jobFlexible hours- Join Takeda as the Director of Global Regulatory Labeling Strategy, based in Boston, MA. You will be responsible for developing and implementing labeling content and strategy for multiple products in various stages of drug development. The role requires 10+ years of pharmaceutical...
$196.4k - $265.7k
...leading biopharmaceutical company in Cambridge, MA is seeking a Director of Medical Writing to lead efforts in drug development... ...track record in medical writing and management, particularly in regulatory submissions. The ideal candidate will possess a strong background...- Merck is seeking an Executive Director of Chemistry, Manufacturing, and Control for Biologics to manage CMC professionals and ensure compliance with global regulatory strategies. This senior role involves overseeing submissions for high-quality CMC for biologics products...
$196.8k - $295.2k
Job Summary The Regulatory Strategy Director will be responsible for the development and implementation of innovative global and regional regulatory strategies for assigned projects within Vertex portfolio. This position will play a major role in shaping cohesive regulatory...Local areaRemote workFlexible hours2 days per week$232k - $348k
Regulatory Strategy Senior Director The Senior Director of Regulatory Strategy leads the development and implementation of advanced global and regional... ...and agency regulatory meetings, committees, and trade associations. Stay current on changing regulations, regulatory...Local areaRemote workFlexible hours2 days per week3 days per week
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