Global Regulatory CMC Lead (Franchise)
Takeda Pharmaceuticals
Takeda seeks an accomplished GRA CMC Franchise Lead in Boston to independently develop and execute regulatory CMC strategies for TAK-079 across clinical development and lifecycle management. You will partner with Regulatory, Development and Commercial teams to drive major global submissions and ensure regulatory compliance. The role requires a proven track record in global CMC submissions, strong leadership, and the ability to communicate complex regulatory strategies to cross‑functional #J-18808-Ljbffr Takeda
- Takeda seeks an experienced GRA CMC leader to drive regulatory strategies and submissions across global programs. You will lead CMC aspects of registrational submissions, coordinate... ...and a Boston, MA location are supported. #J-18808-Ljbffr Orangetheory - Franchise #0137FranchiseRegulatory
$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
- Rhythm Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory chemistry, manufacturing, and controls deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical...Regulatory
- A global healthcare firm is seeking a Regulatory CMC Lead in Boston, MA. The role requires expertise in regulatory strategy, operations, and planning for CMC aspects of assigned projects. Candidates should possess strong communication skills and a minimum of 3-5 years in...Regulatory
- 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
- 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
$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$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- ...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
$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$210.9k - $379.2k
...partners worldwide, contributing to global health initiatives.... ...is seeking a Global Medical Lead to lead medical affairs strategy... ...will interface extensively with regulatory, clinical, commercial, and... ...programs, aligning with broader franchise objectives. Partnering...FranchiseRegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwide$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
$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
...advanced program that integrates clinical, regulatory, CMC, medical affairs, and commercial... ...Regulatory Affairs to develop and execute a global regulatory strategy, including FDA,... ...discipline. Experience as a Global Franchise Lead or equivalent role with direct commercial...FranchiseRegulatory- ...Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection... ...CAPA closures. The position demands deep regulatory knowledge, experience with multiple... ...enabling continuous operational excellence in a global #J-18808-Ljbffr Vertex PharmaceuticalsRegulatory
- 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
- ...CRISPR Therapeutics is a leading biopharmaceutical... ...development of the Zugo-cel CAR-T franchise at CRISPR. Reporting to the Head of Regulatory Affairs, you will work... .... As the Regulatory CMC lead for these programs,... ...collaboration with CMC and global development teams, and...FranchiseRegulatoryContract workRemote work
- Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets, including monoclonal antibodies... ...external CMOs to align with FDA/EMA expectations and global health authority standards. The role requires deep CMC...Regulatory
- 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
- Hongene Biotech is seeking an Associate Director / Senior Manager in CMC Project Management in the Boston area. The role reports to the VP, Global Head of CMC & Regulatory and strengthens project management for oligonucleotide contract manufacturing services. Senior/AD...RegulatoryContract 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
- Vertex Pharmaceuticals Inc is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies and submissions across small molecule programs. The role emphasizes strategic leadership, Health Authority...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
$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$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
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