- Notified (Woburn, MA)
- …design and implement robust security solutions? If so, we invite you to join and lead our security efforts. The Opportunity The CISO / Sr. Director role will be the ... controls (eg, SailPoint), encryption protocols, and cloud-native security solutions. Lead the selection, implementation, and ongoing management of security tools… more
- ConsultNet (Andover, MA)
- …checking for completeness and accuracy based on operational standards and regulatory requirements.Act as client relationship lead for due diligence ... and non-resident tax (Chapters 3 and 61), FATCA (Chapter 4) and global AEOI requirements are of particular interestApplicants with prior experience in complementary… more
- Sanofi Group (Cambridge, MA)
- **Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ or Cambridge, MA **About the job:** Our team is involved in developing regulatory ... you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully accountable… more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... for assigned programs. **How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co- lead and facilitate product-specific … more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Sanofi Group (Cambridge, MA)
- …member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL) , the Regulatory Strategist (RS) leverages ... on the TPP, business planning, governance and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT strategic position on… more
- Merck (Boston, MA)
- …Looking for someone with a growth mindset. **Position Description:** The Senior Director, Global Regulatory Lead , is responsible for development and ... final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory … more
- Merck (Boston, MA)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our company's… more
- Sanofi Group (Cambridge, MA)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise ... to contribute to the definition of the global regulatory strategy, to enable and drive...governance, and committees + May serve as a regional/local regulatory lead and point of contact with… more
- ThermoFisher Scientific (Waltham, MA)
- …purchasing convenience and pharmaceutical services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and ... activities revolve around developing and maintaining the team's capabilities for regulatory activities that support the LPE business portfolio throughout its product… more
- Takeda Pharmaceuticals (Boston, MA)
- …Demonstrated ability to lead cross-functional teams, develop and implement global regulatory strategies, facilitate approvals, resolve complex issues, and ... immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key...partner/health authority audits and inspections. Leadership + Ability to lead , motivate, mentor, and manage a diverse team in… more
- Takeda Pharmaceuticals (Boston, MA)
- … Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a ... sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the...lead complex outsourcing projects. + Deep understanding of regulatory information management + Savvy and effective negotiation skills… more
- Merck (Boston, MA)
- … Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's ... and teams as assigned. **Key Accountabilities:** + Directs activities of the General Medicine global regulatory therapeutic area and team leading to global … more
- Sanofi Group (Cambridge, MA)
- …+ Prepare, review, and approve regulatory design control deliverables. + Lead and/or support global filing activities for device aspects of combination ... **Job title: Device Regulatory Lead (Associate Director)** + Location:...Swiftwater, PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with ... changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or … more
- Takeda Pharmaceuticals (Boston, MA)
- … global brand strategy, incorporating cross-functional strategies (eg Commercial, Regulatory , and Region/country medical partners, and others, as appropriate). + ... Lead development and execution of the global ...regulatory authorities. + Develop, support, and prioritize a global KOL engagement strategy for the respective diseases. +… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** This position is for an Executive Director, Global Development Lead within the GU Therapeutic Area. The Global Development Lead will be ... + Work across the organization and on the cross-functional Global Development Team to lead , develop and...and delivery of trial results + Accountable for integrating regulatory , statistical and other internal and external stakeholder input… more
- Quantis (Boston, MA)
- …developing new service offerings that are grounded in latest science and business strategy. The Global Lead oversees a global team of subject matter experts ... alignment with client needs. Using strong organizational and leadership skills, the Global Lead guarantees seamless alignment and coordination across global… more
- Abt Global Inc. (Cambridge, MA)
- …rewarding and meaningful work? Now's your chance. **The Opportunity** Reporting to the Global Compliance Lead , you will be contributing to the company's ... improve policies, procedures and processes to ensure compliance with regulatory , contractual and company requirements, + Support Program Delivery... Global Quality Management System + Support the Global Compliance Lead to foster a mature… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and implement therapeutic area strategies across the Franchise and in regions. + Lead brand planning process across Neuroscience GPLS ( Global Portfolio & Launch ... + Represent the commercial point of view for business development opportunities. + Lead Commercial sub-team within Global Program Teams to shape clinical… more
