Global Regulatory Affairs Executive Director
Initial Therapeutics, Inc.
Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs. You will serve as the Global Regulatory Leader and US Regulatory Lead, guiding IND/CTA/NDA/MAA submissions and lifecycle management across regions. The role requires extensive experience with regulatory submissions, health authority interactions, and cross-functional leadership. Hybrid work schedule with on-site expectations and potential for expanded leadership #J-18808-Ljbffr Initial Therapeutics, Inc.
- ...Job Description As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit‑for‑phase regulatory strategies for small molecule...SuggestedTemporary workLocal area
$238k - $374k
...we push the boundaries of what is possible in order to bring life‑changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product, you will provide strategic leadership and development to global...SuggestedMinimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and... ...communication and leadership skills. This role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema Pharma AGSuggested
- Chief of Staff, Senior Director Global Regulatory Affairs The Chief of Staff (CoS) serves as a strategic partner to the VP, Head of Global Regulatory... ..., enabling effective leadership, decision making, execution, and communication across the Global Regulatory Affairs...SuggestedHourly payTemporary workWork at office
$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- ...Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is... ...assessments and regulatory recommendations to executive management with. Proactively informs AST and management...Temporary workWorldwide
$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...- ...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...
- ...A leading oncology biotech company in Boston seeks an Executive Director of Global Regulatory Affairs. This crucial role involves providing strategic regulatory leadership for oncology programs, ensuring compliance, and overseeing global regulatory strategies. The ideal...
- Takeda is seeking a VP Head of Executive Compensation in Boston, MA to lead the design and implementation of executive compensation and... ...successful candidate will have over 10 years of experience in global compensation, with a strong emphasis on executive compensation,...
- ...Initial Therapeutics, Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product...
- 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...
$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates should...- Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for multiple programs. The role oversees IND/CTA/NDA/MAA submissions, health authority interactions, and lifecycle management. Hybrid work with on-site days is expected...
- 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...
- Vertex Pharmaceuticals Inc. is seeking a Regulatory Labeling Director to lead strategic development of global labeling for marketed products, including CCDS and regional labeling (PI, PIL, IFU) across US, EU, GB, and CA. The role interfaces with FDA, EMA, and Health Canada...
- 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...
$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$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... ...A Bachelor's degree and 7+ years in Regulatory Affairs is required. Offering competitive salary ($210-...Remote jobFlexible 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...- 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...
$177k - $278.08k
...patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible... ...documentation. Develops and executes a labeling implementation plan to... ...including clinical, safety, medical affairs, and commercial. Builds relationships...Full timeTemporary workLocal areaWorldwide- Moderna is seeking a senior Regulatory leader to guide development and execution of global regulatory strategy for its oncology portfolio. You will shape pathways for novel therapies and drive global development and registration strategies with executive-level impact....
- AstraZeneca in Boston is seeking a Director of Regulatory Affairs Strategy for Cell Therapy to shape global regulatory strategies for breakthrough CGT programs across oncology, immune-mediated and rare diseases. You will lead cross-functional teams, drive Health Authority...
- Accounting Policy & Strategy (VP / Principal / Director) - Insight Global, Boston, MA Our client is a leading global Private Equity & Investment... ...offers the unique opportunity to interact frequently with executives in the Office of the CFO, Office of the CEO, Deal Team,...Work at office
- 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...
$270k - $330k
...The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic leadership to assigned program(s) and implementing regulatory tactics to support the execution of regulatory activities across assigned region(s) or globally, while...Temporary workLocal areaWorldwideFlexible hours- 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...- ...Pharmaceuticals Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for development programs and... ...will have a strong understanding of regulatory affairs frameworks and a minimum of 8 years experience in...
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