- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead , GRAD Oncology. You will ... for complex or highly complex or multiple projects. May lead the Global Regulatory Teams...project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. +… more
- AbbVie (Waltham, MA)
- …Tok (https://www.tiktok.com/@abbvie) . 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
- Takeda Pharmaceuticals (Boston, MA)
- … strategy and coordinating life cycle activities across the portfolio of PDT products. The Global Regulatory Lead , Director , in PDT R&D: + Serves ... as the global regulatory lead for one or more projects and and includes leadership of the Global Regulatory Team (GRT) composed of core regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- … Director will lead all submission types. + Accountable for building global regulatory strategies as defined within the GRT and ensure those are ... opportunities. + Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies on product specific… more
- AbbVie (Cambridge, MA)
- …product(s) within Neuroscience and supports the Manager (Senior Manager, Associate Director , Director ( Global Regulatory Lead (GRL)), in the ... + Skill Set: Proven skill at implementing successful US and Canada regulatory strategies, global regulatory experience is a plus. Experience working in a… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for ... reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management** - Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be… more
- Bayer (Cambridge, MA)
- …brilliant and diverse minds to make a real difference, there's only one choice.** **Senior Director , Global Regulatory Leader-IVD** The Senior Director , ... Global Regulatory Leader-IVD acts as a regulatory strategy lead primarily for Cell &...AND RESPONSIBILITIES** The primary responsibilities of this role, Senior Director , Global Regulatory Leader-IVD are… more
- Fresenius Medical Center (Waltham, MA)
- …products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the ... strategies, and potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning, preparation, and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... Team lead role, prepares and maintains relevant regulatory ...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …Autonomy + Responsibility in line with Associate Director level position; independently lead HE projects and support the Global Health Economics Center of ... appropriate comparator + Co- lead with Market Access the development of the global value proposition to ensure a compelling value story for payers + Identify and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Comprehensive understanding of the pharmaceutical industry and medical affairs + Global regulatory expertise with demonstrated strong ability for collaboration ... best of my knowledge. **Job Description** **Role Objectives:** + The Group Lead , Global Scientific Communications has ultimate accountability for delivering and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …be key in facilitating cross-functional engagement with stakeholders across Clinical Development, Global Regulatory Affairs, Global Manufacturing Sciences, ... specific product launch and champion our GPLS Launch Community of Practice (CoP). As the Global Launch Excellence Lead , you will work with a Product Strategy … more
- Rhythm Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- Manulife (Boston, MA)
- …in office, 2 days from Home; Remote working arrangement is not available;** As Director of Cybersecurity Compliance Program (CCP) for John Hancock, you will be a ... the CCP Program manager. You will be responsible for all cybersecurity regulatory compliance activities carried out for our Life Insurance, Long-Term Care,… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- In this key leadership role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving ... cell transplant. In this position you will build and lead a cell medicine regulatory affairs team...Responsible for the strategic company guidance on FDA and global regulatory requirements (affairs and CMC) for… more
- Bristol Myers Squibb (Cambridge, MA)
- …the regulatory landscape, assessing regulatory risk, and developing global filing strategies. + Co- lead marketing application submission teams for ... more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of… more
- Chewy (Boston, MA)
- … Director , Global Compliance & Ethical Sourcing** will define and lead the company's regulatory compliance strategy, ensuring full adherence to FDA, ... and competitive regulatory intelligence, while ensuring compliance with global regulatory frameworks, including EU feed/food regulations, Canadian CFIA… more