- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Lead , GI & Inflammation where you will ... define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
- AbbVie (South San Francisco, CA)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- BeiGene (Emeryville, CA)
- **General Description** **_:_** + The Director, Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... on Health Authority interactions. + Uses extensive knowledge of global regulatory requirements and the ability to...a global strategy and can develop and lead execution of holistic regulatory strategy while… more
- Novo Nordisk (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions + Serve as a member… more
- Bristol Myers Squibb (Princeton, NJ)
- …Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier ... personal lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products… more
- Novo Nordisk (Lexington, MA)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... on development strategies, and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed Team in defining and executing the … more
- Bank of America (Charlotte, NC)
- Global Regulatory Reporting Observation Management Lead Charlotte, North Carolina **Job Description:** At Bank of America, we are guided by a common purpose ... to make a difference. Join us! **Job Description:** The Global Regulatory Reporting (GRR) function, a part...+ Experience in providing thought leadership and ability to lead without direct authority **Skills:** + Critical Thinking +… more
- Lilly (Indianapolis, IN)
- …The purpose of the Senior Director/Executive Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement ... acceleration strategies. Identify and effectively communicate regulatory risks. + Lead Global Regulatory Team in the development of RSD(s) for assigned… more
- Takeda Pharmaceuticals (Columbus, OH)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... for assigned programs. **How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co- lead and facilitate product-specific … more
- Bank of America (Charlotte, NC)
- Quality Assurance Lead for Global Regulatory Reporting - US Charlotte, North Carolina **Job Description:** At Bank of America, we are guided by a common ... structure for the LOB. This role aligns to the Global Regulatory Reporting (GRR) Team within the...Quality Assurance (QA) function for GRR-US. This individual would lead a matrix team across locations and will work… more
- AbbVie (North Chicago, IL)
- …our talent pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, ... + Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers. + May lead the Labeling Regulatory Strategy… more
- Chiesi (Cary, NC)
- …that "Every one of us is different. Every one of us is Chiesi." **Purpose** The Global Regulatory Lead contributes to the Company's success by managing the ... Global Regulatory Affairs Manager Date: Sep 14, 2024 Department: Global Regulatory Affairs Job Type: Direct Employee Team: R&D, Pharmacovigilance & … more
- AbbVie (Irvine, CA)
- …for development, communication, and execution of US regulatory strategic plans to Global Regulatory Lead (GRL) and project team. Plans and prepares ... of regulations for device products, leads, and participates in global regulatory product teams, interprets regulations, and...of submissions to FDA as a primary contact and lead meetings with FDA. + + + Essential Skills… more
- AbbVie (South San Francisco, CA)
- … HA requirements. 6. Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the ... to our talent pipeline and considered for future opportunities. Global Regulatory Affairs Strategy roles (US and...such as meeting requests &/or briefing book activities), & lead draft review meetings. 9. Advise internal cross-functional team… more
- Takeda Pharmaceuticals (Columbus, OH)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Sanofi Group (Waltham, MA)
- …disease. The position is within the Flu/Respiratory Syncytial Virus Franchise, reporting to the Global Regulatory Lead (GRL). We are an innovative global ... the delivery of business objectives. In this role you will: + Enable the Global Regulatory Lead (GRL) to provide regulatory position to support business… more
- Sanofi Group (Cambridge, MA)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise ... to contribute to the definition of the global regulatory strategy, to enable and drive...governance, and committees + May serve as a regional/local regulatory lead and point of contact with… more
- ICU Medical (UT)
- …experience. Ensures alignment with Regulatory Management as appropriate. * Acts as Global Regulatory Lead on the cross functional teams developing and ... Affairs is a working Manager who assists in development and execution of Global Regulatory Strategies and Plans to assure that new products and changes… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Regulatory Operations to ensure e-CTD compliance. + As required, serves as a global regulatory lead on a specific or assigned clinical program. ... illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory guidance to cross-functional project teams responsible for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) ... global health authority query (HAQ) tracker and archiving regulatory correspondences. + Support DSUR/PBRER preparation by attending Kick-off Meeting,… more