- Merck & Co. (Boston, MA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) ... physician-scientist to join our group as a- Principal Scientist (Clinical Director ) in Translational Medicine/Early Clinical Development in the Cardiovascular and… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will ... define, develop and lead global strategies to maximize global ...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , Global Regulatory Affairs in Cambridge, MA ... with the following requirements: Master's degree in Pharmacy, Biomedical Engineering, Regulatory affairs or related field plus 7 years of related experience.… 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 ... life-changing therapies to patients worldwide. Join Takeda as a Director GRA CMC where you will independently develop and...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… 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:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory ... approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures… more
- Merck (Boston, MA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... release from our company to external agencies and investigators. + Represents Global Regulatory Affairs (GR) within internal committees to provide … more
- Regeneron Pharmaceuticals (Cambridge, MA)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus ... on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- AbbVie (Waltham, MA)
- …assist with the scientific review, development, execution and communication of affiliate/area/ global medical affairs sponsored or supported clinical research ... preferred. Will consider remote candidates. Purpose: The Associate Medical Director /Associate Scientific Director provides specialist medical/scientific strategic… more
- AbbVie (Cambridge, MA)
- …understanding of relevant therapeutic area required. + 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred. + ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more
- AbbVie (Cambridge, MA)
- …statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + Experience in Neuroscience/Psychiatry preferred. + May assist as consultant ... be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational input into core… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation where you will ... define, develop and lead global strategies to maximize global ...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Merck (Boston, MA)
- …up with the latest regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and ensure submission readiness in all ... **Job Description** The Executive Director , Device Quality & Regulatory will...emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as… more
- Sanofi Group (Cambridge, MA)
- …of patients around the world. **Medical Director ** **- Global Medical Evidence Generation** supports disease registries, post- regulatory authorization ... **Job Title:** Medical Director - Global Medical Evidence Generation...with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial… more
- Takeda Pharmaceuticals (Boston, MA)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong… more
- Takeda Pharmaceuticals (Boston, MA)
- …of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and ... unexpected events. + He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates ... patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Actalent (Boston, MA)
- …+ Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, DSURs and Agency briefing ... the technical team and Regulatory teams. Develop and implement global regulatory CMC strategies that maximize probability of success. + Support the… more
