- Merck & Co. (Boston, MA)
- …other pharmacometric analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills:Drug Discovery Process, Global Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple… 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
- 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
- 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
- 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
- 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:** + Independently ... Authorities, as required. + 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
- 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)
- …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
- 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
- CBRE (Providence, RI)
- Regulatory Change Management Director Job ID 215809 Posted 21-Apr-2025 Service line Corporate Segment Role type Full-time Areas of Interest Legal Location(s) ... United States of America **About The Role:** As a Regulatory Change Management Director at CBRE, you...with 8-12 years of relevant experience. + Ability to lead the exchange of sensitive, complicated, and difficult information,… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across ... design through regulatory submissions to post-market safety surveillance. You will lead a global team of product managers and work cross-functionally to… more
