- Merck & Co. (Boston, MA)
- …pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, the Executive Director may be ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- 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 (Waltham, MA)
- …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
- Sanofi Group (Cambridge, MA)
- **Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ or Cambridge, MA **About the job:** Our team is involved in developing regulatory ... you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully accountable… 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
- Takeda Pharmaceuticals (Boston, MA)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …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 (Cambridge, MA)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... expertise to contribute to the definition of the global regulatory strategy, to enable and drive...management of products. + May serve as a regional/local regulatory lead and point of contact with… 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
- AbbVie (Waltham, MA)
- …with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director, or Director), in ... Description Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or… more
- Actalent (Boston, MA)
- … regulatory CMC strategies to support gene therapy development. Key Responsibilities + Lead global Regulatory CMC strategic guidance and provide tactical ... Position: Director/Sr. Director of Regulatory CMC Location: Charlestown, MA About the Role... Affairs for biologics, including involvement with IND activities, global CTAs, DSURs, and Agency briefing documents both in… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …as an Associate Director, Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business ... Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is responsible for global device regulatory strategies and activities for the PDT… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drive process enhancement and continuous improvement initiatives in Patient Access + Lead regulatory inspections and audit support for Patient Access, including ... of continuous improvements, training and best practices to ensure regulatory compliance and consistency for Takeda Patient Access programs....You will report to the Head of Patient Access, Global Medical. **How you will contribute:** + Lead… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs Marketed Products you will define, develop and lead global strategies to maximize global regulatory success towards achievement of ... opportunities. + Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies on product specific… more
- Takeda Pharmaceuticals (Boston, MA)
- …Demonstrated ability to lead cross-functional teams, develop and implement global regulatory strategies, facilitate approvals, resolve complex issues, and ... immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key...partner/health authority audits and inspections. Leadership + Ability to lead , motivate, mentor, and manage a diverse team in… more
- Randstad US (Cambridge, MA)
- usa - manager global regulatory affairs (1st shift). + cambridge , massachusetts (remote) + posted today **job details** summary + $116.13 - $138.17 per hour + ... global product team-oriented environment and ensures close collaboration within the Global Regulatory Affairs CMC & Device organization and with other PDT… more
- Takeda Pharmaceuticals (Boston, MA)
- … Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a ... sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the...lead complex outsourcing projects. + Deep understanding of regulatory information management + Savvy and effective negotiation skills… more
- Takeda Pharmaceuticals (Boston, MA)
- …Liaises with the US FDA on submissions within their responsibilities. + Serves as the lead interface between PDT global regulatory affairs, global ... patients with immunologic, hematologic, and other complex diseases. The Regulatory Lead is accountable for recommending and... for one or more projects and coordinates the Global Regulatory Team (GRT) meetings composed of… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory guidance on Human Factors to product teams in line with global regulatory strategies + Develops strategies, tools and trainings to develop the ... regulatory filings through clinical development and commercial product lifecycle + Lead regulatory strategy, briefing book authoring and meetings with … more
