- Fresenius Medical Center (Waltham, MA)
- …+ 12+ years of experience in regulatory affairs , focusing on regulatory strategy, submissions, and global market access in the pharmaceutical industry. + ... Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical...a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred.… 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 ... tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals… more
- AbbVie (Waltham, MA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . 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
- Evident Scientific (Waltham, MA)
- Executive Director , Regulatory Affairs & Quality Assurance. Job ID #: 2023 Company: Evident Posting Date: Jun 3, 2025 **Working Location:** **MASSACHUSETTS, ... every day. **Let's inspire healthier lives, together.** **Job Description** The Executive Director , Quality and Regulatory Affairs (Exec Dir QARA),… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** About the role Join Takeda as an Associate Director , US Medical Affairs Sponsorship where you will strategically develop and ... it will engage with other business units and functional groups, such as Global Medical Affairs , Oncology, and Medical & Commercial teams. * Embedded… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …plans in Immunology- and Infectious Disease-related therapeutic areas. Develop and lead Medical Affairs initiatives and strategies aligned with the global and US ... Innovation Office and commercial functions. 2. Support development of global and US medical affairs plans in...**Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in… more
- Bristol Myers Squibb (Devens, MA)
- …Management, site and above site QA and QC, Internal and External Manufacturing, Regulatory Affairs and Brand teams. The individual provides end-to-end global ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Cell Therapy Global Product Quality (CTGPQ) is… more
- Olympus Corporation of the Americas (Westborough, MA)
- …adequate support at global and regional levels. + Ensure the appropriate global regulatory requirements, are considered as part of due diligence and ... is maintained, well-organized and ready to be audited by global regulatory authorities / notified bodies. +...preferred. + Minimum of 15 year of directly related Regulatory Affairs experience; preferably a minimum of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). + Minimum of 5… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Field Medical, Medical Information, Program Management; other USBU Stakeholders; and Global functional groups such as Medical, Publications, Regulatory , ... the best of my knowledge. **Job Description** Join Takeda as Associate Director , US Medical Communications Dermatology/Immunology out of our Lexington, MA office.… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …regulatory filings (IND, study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions + Serve as program medical expert ... the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working...than 110 countries and regions. **Position Overview:** The Medical Director will be responsible for clinical strategy relating to… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions + Coordinate interdepartmental ... the best of my knowledge. **Job Description** **About the Role:** The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device… more
- Liberty Utilities (Londonderry, NH)
- …regulated utilities in the East region. This position is responsible for all regulatory affairs and rates related functions in multiple jurisdictions. The ... Manager will support the Regional Director , on other regulatory matters and organizational...America and internationally, we are continually demonstrating our "Think Global , Act Local" business model.** **What we offer** Company… more
- ThermoFisher Scientific (Waltham, MA)
- …Fisher as a leader in the CRO industry and was one of the largest global transactions in 2021. Other transactions spanned the scope of our entire business including ... + Manage the external and internal legal teams responsible for the legal affairs relating to Corporate Development, M&A and Strategic Capital in an efficient and… more
- Curia (Hopkinton, MA)
- …to products, processes, and services to achieve a consistent approach to Quality Assurance and Regulatory Affairs + Acts as a key point of contact with customers ... quality leadership and drives Quality decisions at the site and also supports regional Director of Quality for global Quality initiatives + Provides hands on… more