- Kura Oncology (Boston, MA)
- …will be responsible for developing, implementing, and providing guidance on US and global regulatory strategies to support development of Kura's oncology and ... drives decisions and actions. Contribute to the development and implementation of regulatory strategies for assigned projects. Lead and oversee the preparation,… more
- EPM Scientific (Bridgewater, MA)
- A leading global pharmaceutical company is seeking an Associate Director of Regulatory Affairs to support regulatory development and post-approval ... ANDA, BLA, OTC, and device categories. Serve as a regulatory lead on cross-functional product development and... submissions and responses to health authorities. Collaborate with global regulatory counterparts to ensure regional compliance… more
- State Street Corporation (Boston, MA)
- As the Global Head of Index Business Strategy within the Chief Business Office, you will develop and execute a holistic strategy to grow our index business across ... business and maintaining close connectivity to the competitive environment, regulatory developments and client needs. We seek a candidate...candidate with deep experience in the index business to lead this new team and drive growth across our… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …cycle management This individual will act as the global clinical pharmacology lead on PDT projects and contribute to regulatory submissions and interactions. ... true to the best of my knowledge. Job Description Director , Clinical Pharmacology Cambridge, MA Hybrid Job Posting Description... filings. Provides resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …area knowledge relevant to mechanisms of action of compounds in remit Regional/ global Regulatory requirements GCP/ICH Emerging research in designated therapeutic ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …communicating with regulatory agencies. Must have experience in global regulatory submission requirements and processes. Program Leadership ... divisional initiatives and may contribute to corporate, cross-divisional, and global initiatives Accountabilities: Program Leadership : Provides strategic scientific… more
- Alkermes (Waltham, MA)
- …DMPK and BA department. He/she will represent as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams. This position ... working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Hands on modeling experience is desirable. Essential… more
- Vertex Pharmaceuticals (Boston, MA)
- Job Description The Associate Director , Facilities & Engineering Operations Quality Assurance is responsible for providing quality support and oversight for ... a timely manner. This role will report to the Director of Quality Validation and Engineering within the Vertex...robust corrective actions, and risk communication. Serve as Quality Lead or provide support for projects of varied size… more
- Abcam (Waltham, MA)
- …the value of Abcam's unique reagent portfolio. This position reports to the Director , Partnership Development and is part of the Strategic Partnerships team located ... for affinity reagents. Continuously generate leads with new and existing global partners identifying opportunities for further growth aligning Abcam and Danaher… more
- Takeda Pharmaceuticals (Boston, MA)
- …opportunities. + Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific ... Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory...oversees direct reports or other staff responsible. The Senior Director will lead all submission types. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead ... success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US...Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies… more
- Takeda Pharmaceuticals (Boston, MA)
- …**How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter ... possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The 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)
- … Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... CMC related matters. + Proven ability to liaise with Regulatory Agencies, having served as lead in...international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug… 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
- AbbVie (Waltham, MA)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… 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 (Boston, MA)
- …development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead , Hematology** proactively defines ... empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to...life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead , develops and implements… 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
- 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
