Director, Global Regulatory Labeling Strategy
Core4ce Careers
Akebia Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to ensure labeling complies with FDA and global requirements. You will influence senior stakeholders, oversee USPI/CCDS labeling, manage SPL submissions, and drive lifecycle labeling from development through post-marketing. This role supports hybrid in-office engagement amid relocation plans to Waltham. #J-18808-Ljbffr Core4ce Careers
$177k - $278.08k
...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of...SuggestedMinimum wageLocal areaRemote workWorldwide$196.7k - $353.4k
...Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be... ...on to articulate clear and compelling global regulatory strategies, highlighting risks... ...and maintenance of the Target Label Profile and the Company Core Data Sheet...SuggestedPermanent employmentFull timeWork at officeWork from home- ...LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing... ...global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as...SuggestedTemporary workWorldwide
$180k - $245k
...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs... ...for developing and executing regulatory strategies that support global product development and registration...Suggested- AbbVie in Cambridge, MA, seeks a Director Regulatory Affairs Global Regulatory Lead (GRL II) for Neuroscience... ...You will develop global regulatory strategies, lead the GRPT, oversee dossier... ...will anticipate risks, coordinate labeling strategies, and mentor junior staff...Suggested
$268.2k - $402.2k
...DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory... ...and implementation of innovative global regulatory strategies for product development... ...data, protocols, safety reporting, labeling and other activities related to the...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$177k - $278.08k
...develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA... .... to ensure alignment with global regulatory requirements and... ...Emerging Markets, Strategy, Labelling, etc.) to ensure effective...Minimum wageLocal areaRemote workWorldwide$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical... ...strategy for the assigned global or regional position and will be responsible... ...data, protocols, safety reporting, labeling and other activities related to the...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$200k - $265k
...opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab across all approved and development-stage...Full timeTemporary workWork experience placementWork at officeWorldwide- ...Ipsen seeks an Associate Director of Global Regulatory Affairs to develop and execute regulatory strategies for assigned biopharmaceutical programs. This role bridges R&D,... ...on target product profiles, indications, and label optimization Lead cross-functional teams to...
- Title: Associate Director, Global Regulatory Affairs Company: Ipsen Biopharmaceuticals Inc. About Ipsen... ..., and execution of regulatory strategies for assigned programs within the portfolio... ...needed. Assess impact on timelines and/or label; proposes remediation where possible....Local areaWorldwide
- Sanofi Inc. in the US seeks a Director of US Advertising and Promotion, Global Regulatory Affairs to provide strategic direction... .... You will lead regulatory strategies, liaise with FDA, and mentor... ...ensure compliant promotion and labeling. The role demands a strong background...
- AstraZeneca plc in Cambridge, MA, invites you to shape regulatory strategy across development, commercialization and life cycle management.... ...ensuring compliance. The role emphasizes collaboration across global, regional, and local regulatory affairs, coaching staff, and...Local area
- Discover International is seeking a Director, Global Regulatory Affairs — Oncology to lead regulatory strategy and execution for oncology programs. You will partner with global clinical development teams to navigate milestones, submissions, and lifecycle activities. The...
- Arbor Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning preclinical and early clinical programs. You will serve as the global regulatory lead and primary contact with FDA and other authorities, guiding...
- AstraZeneca seeks a seasoned Regulatory Leader to guide strategic regulatory activities across development, launch, and... ...You will influence authorities and collaborate with global teams to shape regulatory strategies and compliance. With 6+ years in regulatory affairs,...Local area
$175k - $225k
Scholar Rock is a late-stage global biopharmaceutical company focused on developing... .... Summary of Position: The Associate Director, Regulatory Strategy, is responsible for the development... ...SOPs, business development, clinical labeling, disclosure) as needed Candidate Requirements...Shift work- Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2 oncology programs, based in Watertown, MA with in-office presence at least 3 days a week. The role will own INDs/CTAs, health authority...Work at office3 days per week
- ...Director-level regulatory affairs position leading global strategy development and market approval efforts for neuroscience products. Responsible for managing cross-functional teams, regulatory dossiers, and lifecycle management while ensuring compliance with global regulations...
$142.5k - $256.5k
The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring... ...)/Advertising and Promotional Labeling Branch (APLB) guidance, and industry... ...regulatory requirements. Guide promotional strategy as the Regulatory Ad Promo...Permanent employmentWork at office$161.6k - $242.4k
Job DescriptionGeneral Summary:The Regulatory Labeling Associate Director will be responsible for strategic labeling... ...one or more products either at the global label-level (CCDS, USPI, EuSmPC) or... ...profiles.Contributes to labeling strategy with a proficient ability to advise...Full timeSummer workWork at officeRemote workFlexible hours2 days per week$154.4k - $242.55k
...Job DescriptionJob Description Objective / Purpose Provides strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of biomarkers, diagnostic tests, devices and digital health tools to...Minimum wageLocal areaRemote work$154.4k - $242.55k
...the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction...Minimum wageLocal area$196.7k - $353.4k
The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters... ...disease vaccines as unprecedented new drug modality globally. The Sr. Director will be a strategic leader within Global...Permanent employmentFull timeWork at officeWork from home- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads... ...programs Implement compliance strategies and processes Prepare, review, and approve... ...sub-working groups, such as the Label Working Group, and represents GRTs at...Full timeLocal area
$212k - $318k
...allow our medicines to reach patients faster than ever before.The Director, T1D will serve as a T1D Market Access Lead within our Cell and Gene Therapy (CGT) portfolio in the Global Value and Access Strategy (GVAS) team.The individual will be responsible for leading the...Full timeSummer workRemote workFlexible hours2 days per week$170.26k - $200.3k
...discover what you excel at—all from Day One.Job DescriptionThe Global Custody Strategy Manager will own the strategy, commercial roadmap, pricing... ..., standardize workflows, and prepare for new products or regulatory change.Convert recurring service issues, inquiry themes,...Full timeWork at officeLocal area- ...Executive Director, Regulatory Strategy About the Company Clinical-stage biopharmaceutical company developing innovative, transformational... ...expanding the regulatory organization to support various global submissions. This is a unique opportunity to shape the team...
$177k - $278.08k
...possible in order to bring life-changing therapies to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of...Minimum wageLocal areaRemote workWorldwide- ...Vertex Pharmaceuticals LLC is seeking a Director of Regulatory Affairs CMC in Boston. The role leads a Regulatory CMC team, shaping global strategies for small molecule programs and coordinating Health Authority interactions across development and commercialization....
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