Global GRA CMC Director: Lead Global Submissions
Takeda
Takeda is seeking an experienced Regulatory CMC Leader in Boston to independently develop regulatory CMC strategy and lead regulatory submissions across the product lifecycle. You will partner with regulatory, development, and commercial teams to drive compliant, timely filings and address agency expectations. The role emphasizes leadership, strong CMC knowledge, and effective communication with Health Authorities, plus mentoring peers in a complex matrix environment. #J-18808-Ljbffr Takeda
$154.4k - $242.55k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...supervision, develops and leads the execution of regulatory... ...of robust and accurate submissions. Develops constructive relationships...SuggestedMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$190.4k - $285.6k
## Director, Global Submission ManagementApplylocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition... ...role partners closely with Major Submission Leads, Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion...SuggestedSummer workRemote workFlexible hours2 days per week$154.4k - $242.55k
...impact on patients worldwide. Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global regulatory... ...regulatory strategies for oncology programs, oversee major submissions, and guide cross-functional teams to bring breakthrough...SuggestedMinimum wageTemporary workLocal areaWorldwide$169.4k - $266.2k
...deliver your best. As part of the Global Medical Affairs Oncology team... ...Communications Group Lead, Solid Tumors. As a subject... ...deliverables, the Associate Director, Scientific Communications Lead... ...slide decks, NCCN or pathway submissions, animations, and digital amplification...SuggestedMinimum wageFull timeFor contractorsWork experience placementFreelanceLocal areaRemote work- Job title: Global Regulatory Strategist Location: Morristown, NJ... ...the oncology therapeutic area, leading regulatory efforts in the... ...with nonclinical, clinical, CMC, commercial, and other internal... ...remit, as needed Regulatory Submissions & Operations Leads submission...SuggestedLocal area
$196k - $269.5k
## Director, Global Indication Lead, RheumatologyApplylocations: Boston, MA, USAtime type: Full timeposted on: Posted Yesterdayjob requisition id: REQ-4319*Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx...Temporary work- Takeda is seeking an Associate Director, Global Regulatory Lead Oncology in Boston, MA. This role involves leading global regulatory strategies for oncology programs, overseeing major submissions, and guiding cross-functional teams to deliver breakthrough treatments. The...Worldwide
- Takeda in Boston, MA seeks an Associate Director, Global Regulatory Lead Oncology to define and lead global regulatory strategies for oncology programs, oversee major submissions, and guide cross-functional teams to bring breakthrough treatments to patients globally. The...
- Vertex Pharmaceuticals in Boston, MA is seeking a Senior Director of Global Value & Access Strategy for povetacicept, focusing on IgA nephropathy. This role involves leading the development of global market access strategies and managing cross-functional teams to ensure...
- Alnylam Pharmaceuticals, Inc. is seeking an Associate Director of International Tax to lead global tax planning and compliance. This hybrid role, primarily located in Cambridge, MA, offers an opportunity to influence tax strategies aligning with business objectives. The...
$196k - $269.5k
argenx SE is seeking a Director, Global Indication Lead, Rheumatology located in Boston, MA. This position involves leading the commercial strategy for key assets, including those for Sjogren’s Disease and Myositis. The ideal candidate will possess extensive experience...- ...International is seeking a Senior Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This key position involves... ...navigate complex regulatory frameworks. You will lead global regulatory submissions and collaborate with cross-functional teams to drive...
$212k - $333.19k
...to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...prospective and proactive implementation. Globally influence and serve as a key... ...related aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs,...Minimum wageFull timeTemporary workLocal areaWorldwideNight shift- Responsibilities Lead development and implementation... ...and communicate CMC/quality guidance and regulations... ...matter expert for global Human Factors regulation... ...device-related global submissions and compliance activities... ...matrix environment across GRA to ensure timely...Night shift
$154.4k - $242.55k
Job Title Lead, Global Pricing, Oncology (Associate Director) Location Cambridge, MA About the role Will lead the development of global pricing strategies and drive operational implementation across multiple launch and in-line assets for the Takeda Oncology Business...Temporary workLocal area$146.3k - $234.1k
...You will be a member of the Global Labeling, Global Regulatory Affairs team and will lead all Labeling activities required for the development and maintenance... ...including leading initiatives for Labeling within GRA or across functions at BioNTech Act as the empowered...Hourly payWork experience placementLocal areaRemote workWorldwide$147k - $212k
...Job Title: GRA Device Lead (Associate Director) Location: Cambridge, MA/ Morristown... ...accelerate progress. The Global Regulatory Affairs (GRA)... ...The team is part of the GRA CMC & GRA Device Department... ...preparing high-quality regulatory submissions, managing compliance, and...Temporary workLocal areaWorldwideFlexible hours- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...
- Voisin Consulting SARL in Boston is seeking an experienced Head of Chemistry, Manufacturing, and Controls to lead the development and execution of global CMC strategy across a diverse therapeutic portfolio including biologics and gene therapies. The successful candidate...
$178.5k - $257.83k
Job title: Global Regulatory Lead Location: Morristown, NJ / Cambridge, MA About the job As the... ...the primary interface and key strategic GRA partner for the Global Project Team (... ...Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling in...$202.5k - $337.5k
Global CMC Automation and Robotics Leader 2 weeks ago Be among the first 25 applicants This... ...humanoid robots across CMC Build and lead a team of advanced automation & robotics... ...Extraordinary - together. Seniority Level Director Employment Type Full-time Job...Full timeLocal area- ...Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at least 8 years of experience... ...with Small Molecule drugs, and a strong understanding of CMC requirements. Key responsibilities include managing submissions...
$153.6k - $241.34k
A leading pharmaceutical company is seeking an Associate Director to define and lead global regulatory strategies. This role requires significant experience in regulatory affairs and offers opportunities for strategic leadership across multiple projects. Located in Boston...$238k - $374k
JobRx, Inc. is seeking an Executive Director for Global Regulatory Affairs CMC Early Development based in Boston. The ideal candidate will provide strategic leadership, overseeing global CMC regulatory strategies for small molecules and biologics through Phase 2, and working...$212k - $333.19k
Senior Director, Global Program Lead - Neuroscience Cambridge, MA Are you looking for a patient-focused... ...pathways through large-scale Phase III/submission projects and global launch projects.... ...Subteam, Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT through function...Minimum wageFull timeTemporary workWork at officeLocal areaRemote work$178.5k - $257.83k
Job Title Director, US Advertising and Promotion, Global Regulatory Affairs Location Morristown, NJ / Cambridge, MA Job Summary In this role, the candidate will serve as the resident expert in GRA US Advertising and Promotion (A&P) group on promotion, labeling, product...- ...centricity and drive organizational change. The ideal candidate should have over 15 years of HR leadership experience, particularly within global and high-growth environments. They should possess a strong analytical mindset, excellent communication skills, and be adept at...
- ...Takeda is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development... ...emphasis on Human Factors, regulatory submissions, and cross-functional collaboration... ...strategies, interfacing with global health authorities, and ensuring high...
$185.37k - $308.95k
...Associate Director, Global Safety Lead Who we are: At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive,... ...investigator brochures and informed consent forms, and regulatory submissions including IND, NDA and PIP/PSP documents. Contributes to...Temporary workRemote workWork from homeFlexible hours3 days per week$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge, United Kingdom and 3 more (Hybrid) Job Description Orion Pharma... ...across all phases of drug development and global regulatory submissions, ensuring quality and compliance through leadership and...Worldwide
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