Global Regulatory CMC Franchise Lead
Takeda
Takeda is seeking a senior Regulatory CMC lead in Boston, hybrid: you will own global CMC strategy and drive major submissions across development and lifecycle. You will collaborate with Regulatory, Development, and Commercial teams, negotiate with Health Authorities, and coach teams to maintain high performance and compliance. The role requires 10+ years in biopharma/regulatory CMC with NDA/BLA/MAA experience, strong leadership, and excellent communication skills. #J-18808-Ljbffr Takeda
$177k - $278.08k
...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...as follows: You will be the GRA CMC Franchise Lead for TAK-079 Independently develops the regulatory...FranchiseRegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$212k - $333.19k
...Join us as a Senior Director, Global Program Lead- Neuroscience in our... ...leadersCommitted to simultaneously driving regulatory approval as well as launch... ..., Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT... ....Consults with TAU, Franchise Leadership and Portfolio Office...FranchiseRegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...Regulatory
$212k - $333.19k
...impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...company objectives.Serve as global regulatory lead (GRL)/ Franchise global regulatory lead (GRL) on cross-functional teams for...FranchiseRegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$196k - $269.5k
...realize our ambitions, the argenx Global Commercial Team is looking... ...Director, Global Indication Lead, Rheumatology.In this key... ...considers short- and long-term brand/franchise impacts, ensuring strong... ...understanding of the legal, regulatory and commercial environment across...FranchiseRegulatoryFull timeTemporary workWork at officeRemote work- Sanofi is seeking a Global Brand Lead for Transplant (Solid Organ Transplant) to lead the end-... ...with Medical Affairs, Market Access, Regulatory, Digital, and regional teams to drive... ...U.S. and reporting to the SVP, Global Franchise Head, you will shape strategy, oversee...FranchiseRegulatory
- Sanofi Inc. is seeking a Global Brand Lead for Transplant (Solid Organ Transplant) based in the... ...Affairs, Market Access, Digital, Regulatory and regional teams to drive global growth... ...environment, with a focus on profitable franchise expansion and external partnerships....FranchiseRegulatory
$232.5k - $335.83k
Job Title: Global Brand Lead, Transplant (Solid Organ Transplant)Location: Morristown, NJ, Cambridge... ...chronic conditions.The Transplant Franchise is a strategic growth driver within... ...Market Access, Corporate Affairs, Digital, Regulatory, and regional commercial teams.Main...FranchiseRegulatoryFull timeLocal area$167k - $300.7k
...diseases, and oncology, we are seeking a Global Competitive Intelligence Lead-Oncology to lead Moderna’s... ...brands and pipeline assets for Oncology Franchise. This individual will lead the... ...competitor pipelines, clinical trial data, regulatory strategies, commercial activities,...FranchiseRegulatoryWork from home- 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...Regulatory
$170k - $220k
A genetic medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication...Regulatory- Moderna seeks an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory CMC activities and developing strategies for transformative medicines. The ideal candidate will have at least 8 years in the biotech space, particularly...Regulatory
- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate CMC regulatory activities across product lifecycles and to develop global strategies that align with business priorities. You will guide product teams, prepare CMC and Quality submissions, and...Regulatory
- Biogen in Cambridge, MA is seeking a Head of Regulatory CMC for Biologics & ATMPs. This hybrid role leads a global CMC regulatory strategy, aligning development, manufacturing, and regulatory activities to ensure timely approvals and lifecycle progression. You will guide...Regulatory
- Moderna is seeking an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC activities across product lifecycles, develop global... ...agency correspondence and regulatory applications. The role leads interactions with health authorities, manages multiple...Regulatory
$251.61k - $377.42k
Global Product Leader, Late CVRM - Weight ManagementAre you an inspiring... ...of the medicines in the franchise.The role reports to the... ...lifecycle. In this role, you'll lead a cross-functional Global Product... ..., including publications, regulatory documents, and clinical trial...FranchiseRegulatoryHourly payFull timeTemporary work$293k - $358k
...Boston 2025 and is backed by leading life sciences investors.... ...program that integrates clinical, regulatory, CMC, medical affairs, and... ...Affairs to develop and execute a global regulatory strategy,... ...discipline. Experience as a Global Franchise Lead or equivalent role with...FranchiseRegulatory- CRISPR Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based... ...complex CMC topics, prepare high-quality submissions, and guide global teams through INDs, CTAs, #J-18808-Ljbffr Crispr...RegulatoryContract workWorldwide
$177k - $266k
...collaborative Director to serve as an Early Stage CMC Program Lead. This role is responsible for end-to-... ...alignment with program objectives and regulatory expectations. The Program Lead will... ...documentation and strategy comply with global regulatory guidelines. Program...RegulatoryFull timeContract workTemporary workShift work- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities across product lifecycles and develop global strategies in alignment with business priorities. You will guide product teams and prepare CMC/Quality regulatory submissions...Regulatory
- ## Associate Director, Regulatory Affairs CMCApplyremote... ...CRISPR Therapeutics is a leading biopharmaceutical... ...of the Zugo-cel CAR-T franchise at CRISPR. Reporting to... ...patients. As the Regulatory CMC lead for these programs... ...collaboration with CMC and global development teams, and...FranchiseRegulatoryContract workRemote work
- Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities....Regulatory
$154.4k - $242.55k
...Brand Insights and Analytics Lead, US Oncology is an Associate... ...force analytics across oncology franchises in partnership with Brand... ...projects simultaneouslyKnowledge of regulatory requirements and compliance... ...work. Certified as a Global Top Employer, Takeda offers stimulating...FranchiseRegulatoryMinimum wageTemporary workLocal areaRemote work$178.5k - $257.83k
Job Title: Lead, US Hematology Pipeline CommercializationLocation... ...close collaboration with the global patient community, and the... ...the US Rare Blood Disorders franchise is committed to advancing care... ...relationship among clinical, regulatory, medical, access, and commercial...FranchiseRegulatoryFull time- Vertex Pharmaceuticals Incorporated seeks a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies across a small molecule portfolio. You will guide content for submissions, engage Health Authorities...Regulatory
- Vertex is seeking an Associate Director of CMC to lead global regulatory strategies for biologics, author submissions, and interface with health authorities, leveraging AI-enabled tools to enhance document quality and efficiency. This role requires 8+ years in pharma/biotech...Regulatory
$212k - $333.19k
...therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you will... ...driving prospective and proactive implementation. Globally influence and serve as a key opinion leader and resource...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwideNight shift$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...assigned programs, ensuring alignment with clinical, CMC, and non-clinical development activities and overall program...RegulatoryLocal areaFlexible hours2 days per week$238k - $374k
...changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will... ...(e.g., US, EU, UK, Japan, China).How you will contribute:Leads and develops a team of regulatory leaders and subject matter...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$238k - $374k
...the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused... ...major regions (e.g., US, EU, Japan, China).ACCOUNTABILITIES Leads and develops a team of regulatory leaders and subject matter...RegulatoryMinimum wageTemporary workLocal areaRemote work
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