Associate Director, Global Regulatory Affairs CMC Lead
USA - 3316 Takeda Development Center Americas, Inc.
Takeda's Global Regulatory Affairs - CMC team in Cambridge, MA is seeking a Regulatory CMC professional to lead regulatory submissions for investigational, registration and post-approval programs across global markets. With minimal supervision, you will define CMC content, develop regulatory strategies, collaborate with cross-functional teams and Health Authorities, and ensure regulatory compliance with Takeda procedures and global requirements. #J-18808-Ljbffr USA - 3316 Takeda Development Center Americas, Inc.
$154.4k - $242.55k
...therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational,...SuggestedMinimum wageLocal areaRemote workWorldwide- ...to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to... ...follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational,...SuggestedWorldwide
- Moderna is seeking an Associate Director, Global Regulatory Affairs, CMC, to lead and oversee regulatory activities for CMC and Quality, coordinating worldwide submissions and agency communications. The role requires 10+ years in pharma/biotech with strong EU/ROW regulatory...SuggestedWork at officeWorldwide
- Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success...Suggested
$154.4k - $242.55k
...a lasting impact on patients worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global regulatory... ...as understanding broad concepts within regulatory affairs and implications across the organization and globally;...SuggestedMinimum wageLocal areaRemote workWorldwide$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing... ...of global products. The successful candidate will lead and support all regulatory activities, ensuring the delivery...Permanent employmentFull timeWork at officeWork from home$142.5k - $256.5k
...The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing... ...of global products. The successful candidate will lead and support all regulatory activities, ensuring the...Permanent employmentWork at officeLocal areaWork from home$161.5k - $218.5k
OverviewThe Associate Director, Downstream, Emerging Modalities... ...purification as well as lead program(s) with the... ...transition by leading CMC team as necessary for... ...Formulation Development, Regulatory, Technical Operations,... .... We're proud to be a globally recognized top...Full timeTemporary workLocal areaFlexible hours$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This role... ...and health authority briefing packages.Lead or help to lead the interpretation of...Full timeTemporary workWork at officeLocal areaFlexible hours$166.4k - $249.6k
...Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of... ...Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical...Summer workRemote workFlexible hours2 days per week$230k - $250k
...Director, Global Regulatory Affairs - Strategy Lead Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. With our transformation into a fully...Work at officeFlexible hours2 days per week- Ipsen Biopharmaceuticals Inc. is seeking an Associate Director, Global Regulatory Affairs in the Cambridge, MA area. The role leads regulatory strategy and execution for development and marketed products, interfacing with R&D, Franchise, and Commercial teams to ensure compliant...
- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston... ...CRISPR Therapeutics is a leading biopharmaceutical company... .... As the Regulatory CMC lead for these programs, you... ...collaboration with CMC and global development teams, and with...Contract workRemote work
$143k - $233k
...will play a key role in regulatory strategy development... ...Manufacturing and Control (CMC) programs. Your Role:... ...accountable for developing and leading the execution of... ...and execute CMC global submission plans and timelines... ...CMC and regulatory affairs leads/SMEs.Independently...- Biogen, Inc. in Cambridge, MA (hybrid) seeks a CMC Commercial Asset Development Lead to guide asset strategy, development, supply, and lifecycle planning... ..., strategic decision making, and collaboration with global teams across IND to NDA/BLA processes, enabling Biogen’s...
- ...Job Description Title: Associate Director, Signal Management & Innovation... ...professional to lead signal detection, evaluation... ...management activities within a global Patient Safety organization... ...Pharmacovigilance, Global Regulatory Affairs, Data Sciences, Medical Safety...Remote job
$154.4k - $242.55k
...Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU)... ...., safety, ad promo, regulatory strategy, medical affairs, etc.). 5-7 years of direct experience in a global...Minimum wageLocal area$154.4k - $242.55k
...to inspire you and empower you to shine? Join us as an Associate Director, Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge, MA... ...documents, clinical protocols and documents submitted to Regulatory Agencies.• Establish and maintain scientific dialogue...Minimum wageLocal area$154.4k - $242.55k
...to teams for the delivery of global regulatory strategies to support... ...Responsible for developing and leading the global regulatory strategies... ...the Global Regulatory Affairs (GRA) function in senior level... ...comments and supporting trade association working groups.Education & Competencies...Minimum wageLocal areaRemote work$147.5k - $221.3k
...DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and... ...forumsKnowledge and Skills:Knowledge of regulatory requirements and inspection... ...or leanProven ability to lead improvement projects and... ...InformationVertex is a global biotechnology company that...Full timeSummer workRemote workFlexible hours2 days per week$142.5k - $256.5k
The RoleThe Global Regulatory CMC Lead will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Lead will be responsible for developing global regulatory CMC strategies...Permanent employmentFull timeWork at officeWork from home$180k - $245k
...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs,... ...is required, and immunology background is preferred. CMC experience is a plus.ResponsibilitiesDevelop and...$210k - $320k
...company committed to establishing the leading, fully integrated platform for... ...serious diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing... ...support for the development of global products. This position will lead...Full timeShift work3 days per week1 day per week- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring... ..., enhancing their skills and knowledge in regulatory affairs Strong strategic planner with a proven ability to anticipate...Full timeLocal area
$147.5k - $221.3k
...Vertex Pharmaceuticals seeks an Associate Director to lead inspection readiness and... ...continuous improvement, and ensure regulatory readiness through audits,... ...~8+ years of relevant CMC quality or compliance experience ~ Knowledge of global regulatory requirements and...- ...Ipsen seeks an Associate Director of Global Regulatory Affairs to develop and execute regulatory strategies for assigned biopharmaceutical programs. This role... ...profiles, indications, and label optimization Lead cross-functional teams to define and execute global regulatory...
- Title: Associate Director, Global Regulatory Affairs Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company... ...benefit from such engagement. In addition, the role leads or contributes to operational excellence initiatives...Local areaWorldwide
- Stoke Therapeutics is seeking a Regulatory CMC Manager to drive global regulatory CMC strategies across multiple programs. You will collaborate with cross-functional teams including Regulatory Affairs and Technical Operations to navigate FDA/EMA requirements. The role...Remote job
- ...JOB TITLE: Executive Director, Global Regulatory Affairs REPORTS TO: Vice President, Regulatory Affairs /... ...enterprise level. The Executive Director will lead global Health Authority engagement... ...Development, Clinical Operations, CMC/Technical Operations, Nonclinical,...
- Takeda in Boston, MA is seeking a Director Regulatory Site CMC to lead site-specific post-approval change management and regulatory submissions across... .... This role requires 10+ years in biopharma with deep global HA regulatory experience, an advanced scientific degree,...
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