- 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 ... timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- AbbVie (Waltham, MA)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Fresenius Medical Center (Waltham, MA)
- …+ ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical portfolio, including IND/CTAs, ... NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning,… more
- Candela Corporation (Marlborough, MA)
- …marketing organizations. **Job Summary Overview and Job Responsibilities** In this position, the Senior Director , Global Compensation and Benefits (C&B) is ... ** Senior / Director , Global Compensation...** Senior / Director , Global Compensation and Benefits** Requisition... regulatory requirements. In this position, the Sr. Director strategizes (with the CHRO) to align global… more
- ThermoFisher Scientific (Waltham, MA)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** The Senior Director , Pharma Services Group (PSG) Global Controller acts as a ... activities of PSG, ensuring compliance with US GAAP, SOX, internal policies, and other regulatory standards. + Lead a team of senior -level divisional and site… 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), will oversee… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Cell Therapy Global Product Quality (CTGPQ) is ... and supports development teams, including comprehensive input into strategy during all global clinical and commercial regulatory filings. This position leads a… more
- Charles River Laboratories (Wilmington, MA)
- …annual forecast. Create monthly and quarterly progress reports and provide the corporate senior management team with input to achieve global sales strategies and ... you can feel passionate about. **Job Summary** Rare opportunity to join the Global Account Management Team. This high profile and challenging role requires a high… more
- Charles River Laboratories (Shrewsbury, MA)
- …career that you can feel passionate about. **Job Summary** This is a senior management position within the company with overall responsibilities for the operations ... with colleagues to develop plans when necessary to address material shortfalls ** Regulatory ** *Ensure that processes fully satisfy regulatory requirements as… 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 ... regulatory documentation is maintained, well-organized and ready to be audited by global regulatory authorities / notified bodies. + Develop an understanding… more
- Bristol Myers Squibb (Devens, MA)
- … Director of Validation, Cell Therapy Technical Operations reports to the Senior Director , Cell Therapy Technical Operations within the Cell Therapy ... via internal and external manufacturing sites. This role will serve as the Global Technical SME for Drug Product and Vector Validation. The lead will develop… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Associate Director , Clinical Research, Value & Evidence Generation, US Medical** **Lexington, MA** ... on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies… more
- ThermoFisher Scientific (Waltham, MA)
- …Quality standards, regulatory requirements and customer expectations are maintained. The Senior Director will champion and pursue and promote a premier ... PPD. For more information, please visit www.thermofisher.com . **Position Summary:** The Senior Director Quality, Large Molecule is an executive level leadership… more
- Takeda Pharmaceuticals (Lexington, MA)
- …regional and global departmental infrastructure, resources, projects, etc. in conjunction with senior staff and global line and function heads + Lead ... and applies outsourcing strategy for department in conjunction with senior staff and global line and function...Regulatory submission experience required with basic knowledge for regulatory guidelines + Global cultural awareness, manage… more
- Hologic (Marlborough, MA)
- …Quality Marlborough, MA, United States San Diego, CA, United States Job Overview: The Senior Director of Mergers and Acquisitions (M&A) Quality is an integral ... part of the global Quality leadership team. This role is responsible for...detailed reports on quality assessments, findings, and recommendations to senior leadership and key stakeholders. + Collaborate with division… more
- ThermoFisher Scientific (Tewksbury, MA)
- …Conditions** Office **Job Description** How will you make an impact? The Director , Procurement Partner is the leader responsible for developing and driving the ... or buy, vendor transition, CSR), monitoring execution and communicating results to senior leaders Ensure alignment with business colleagues within the Group and… 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 ... and investment agreements. + Advise Corporate Development, Strategic Capital, and other senior leaders on issues related to the inorganic growth pipeline, including… more
- Fresenius Medical Center (Lexington, MA)
- **PURPOSE AND** **SCOPE:** The Senior Associate, in this management role, will support the Director of Treasury Centers. The position would be a member of the ... broader Corporate Finance and Global Treasury (CFGT) team that has been established over...to ensure the companies Treasury needs are met. The Senior Associate can expect to work closely with all… more
- Celestica (Merrimack, NH)
- …degree in Finance, Accounting, HR, or a related field. This role reports into the Director of Global Payroll Operations located in Toronto, Canada and will be ... Stream** : Payroll & HR Services (HRM_PHRS) **Role** : Senior Manager **Job Title** : Senior Manager,...Mexico employees.** Ensure payroll processes are in compliance with regulatory as well as internal control requirements; stay informed… more
- Bristol Myers Squibb (Devens, MA)
- …+ Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. + High problem-solving ability/mentality, ... here at BMS with our Cell Therapy team. The ** Senior Specialist, QC Materials Management** is responsible for the...stationed in Devens, MA and reports to the Associate Director , QC Systems and Support. **Shifts Available:** Monday -… more