Director, Global Regulatory Strategy
BioSpace
A global biopharmaceutical company is seeking a Director of Regulatory Affairs to lead the Global Regulatory Strategy. This role involves developing strategies for securing market approval, ensuring compliance with regulatory requirements, and mentoring team members. Candidates should have a Bachelor's degree in life sciences and over 7 years of regulatory experience, along with strategic leadership skills. This position is crucial in coordinating cross-functional teams and managing projects to navigate complex regulations. #J-18808-Ljbffr BioSpace
- ...Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the...SuggestedWorldwide
$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...SuggestedPermanent employment- ...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs... ...for developing and executing regulatory strategies that support global product development and registration...Suggested
- 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...Suggested
$177k - $278.08k
...boundaries of what is possible in order to bring life‑changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple...SuggestedFull timeTemporary workLocal areaWorldwide- 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...
$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$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- 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...
- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of... ...vaccines based on messenger RNA technology in the US and other global markets. Responsibilities Serve as the global...
- ...company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires... ...particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and...
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies for the company's early-stage and pipeline programs in the immunology and inflammation (I&I) therapeutic area, with...Local areaFlexible hours2 days per week$209.35k - $258.6k
Akebia Therapeutics is seeking a Director of Regulatory Labeling in Cambridge, MA. This key role involves leading global labeling strategies across product life cycles and ensuring compliance with regulatory standards. The ideal candidate will have 10+ years of pharmaceutical...- Vertex Pharmaceuticals Inc (US) in Boston is seeking a Regulatory Strategy Associate Director to oversee the development of global regulatory strategies for their portfolio. The role involves leading regulatory submissions and mentoring team members on regulatory frameworks...
- ...Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high-impact oncology programs. You will collaborate with cross-functional teams to...
$192.4k - $260.4k
Overview The Director, Head of Global Trade Compliance and Strategy is a key supply chain leader responsible for designing, implementing, and overseeing the... ...trade policy and strategy direction, drive proactive regulatory engagement, and partner with senior and executive...Full timeTemporary workLocal areaFlexible hours$245k - $300k
Merida Biosciences in Cambridge, MA is seeking a Sr. Director, Regulatory Affairs to lead and execute global regulatory strategies. The ideal candidate will oversee health authority interactions, regulatory submissions, and strategic guidance for innovative therapeutics...- Hemab Therapeutics is seeking a Director of Regulatory Affairs to develop and execute global regulatory strategies for rare hematologic disorders. You will lead complex submissions, guide cross-functional teams, and interact with health authorities to advance innovative...
- Scholar Rock is seeking a Director or Senior Director of Regulatory Strategy in Cambridge, MA. This role involves developing global regulatory strategies, representing regulatory affairs within program teams, and ensuring compliance for pipeline programs. The successful...
- ...leading oncology biotech company in Boston seeks an Executive Director of Global Regulatory Affairs. This crucial role involves providing strategic... ..., ensuring compliance, and overseeing global regulatory strategies. The ideal candidate will have over 15 years of...
- JobRx, Inc. is looking for a Director to define and lead global regulatory strategies in Boston, MA. The ideal candidate will manage the Global Regulatory Teams, ensure compliance with regulatory requirements, and oversee all FDA submissions. The role demands strong leadership...
- Discover International is seeking an experienced Associate Director / Director in Global Regulatory Affairs CMC to lead regulatory strategy and execution. This role involves developing CMC strategies for complex pharmaceutical products and guiding major submissions. The...
- Initial Therapeutics, Inc. is seeking a Senior Director to lead global regulatory strategies in Boston. This role requires extensive experience in regulatory affairs and a strong background in drug development. The ideal candidate will have over 12 years in the pharmaceutical...
- 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...
$212k - $333.19k
Takeda is seeking a Senior Director to define and lead global regulatory strategies in Boston, MA. This role requires over 12 years of experience in the pharmaceutical industry, with a strong emphasis on regulatory submissions and compliance. The ideal candidate will have...- Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic role involves developing and executing regulatory strategies to support global product development, particularly in immunology. The successful candidate will have at...
$196.7k - $353.4k
A leading biotechnology firm in Cambridge, Massachusetts, is seeking a seasoned regulatory leader to drive global regulatory strategy for their oncology portfolio. Responsibilities include leading regulatory submissions, health authority interactions, and developing high...- Vertex is seeking a Regulatory Strategy Senior Director based in Boston. You will lead the development and execution of global and regional regulatory strategies for development programs and for Vertex medicines, shaping cohesive plans that support the franchise strategy...Local area
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...
$211.5k - $258.5k
BioSpace is seeking a Director, Regulatory Strategy to manage global regulatory strategies for early-stage programs in immunology and inflammation. This hybrid role requires expertise in FDA and EMA submission processes and leading regulatory interactions. Qualifications...
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