- Merck (North Wales, PA)
- **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director /Senior ... their assigned projects. **Position Description** The Principal Scientist / Director responsibilities include but are not limited to: +...+ Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or… more
- Novo Nordisk (Plainsboro, NJ)
- …multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions + Serve as a ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- J&J Family of Companies (Trenton, NJ)
- Director , Global Regulatory Leader (GRL) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global ... more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead...exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent… more
- Bristol Myers Squibb (Princeton, NJ)
- …Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier ... personal lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …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
- J&J Family of Companies (Trenton, NJ)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory Medical ... potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a...plan, assessment aid) documents is preferred. + Knowledge of global regulations, regulatory timelines, guidelines, and … more
- Bristol Myers Squibb (Princeton, NJ)
- …teams on practical aspects of global change management. **Responsibilities** Represent regulatory CMC on and/or lead matrix teams for biologics pipeline ... of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with...to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for… more
- Ascendis Pharma (Princeton, NJ)
- …US & Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy . ... for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will...for the United States and the Americas and supporting global needs as required. The RA Associate Director… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… more
- Taiho Oncology (Princeton, NJ)
- …Summary: Under the leadership of Regulatory Affairs the incumbent manages global regulatory operational activities (except Asia) for all Taiho Oncology, ... Associate Director , Regulatory Affairs Operations Pleasanton, CA,...contract review and negotiation. + Strong working knowledge of global regulatory requirements and submission processes. +… more
- Bristol Myers Squibb (Princeton, NJ)
- …the regulatory landscape, assessing regulatory risk, and developing global filing strategies. + Co- lead marketing application submission teams for ... more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of… more
- Merck (West Point, PA)
- …creative conflict resolution and problem-solving skill. + Strong knowledge of global regulatory guidelines and cGMP principles. + Demonstrated experience ... a highly motivated individual for the role of Associate Director , Tech Transfer Leader in Large Molecule...TT teams. + Required to comply with our Company Global and regulatory requirements and execute current… more
- Bristol Myers Squibb (Princeton, NJ)
- …while advancing professionally alongside some of the brightest minds in biopharma. The Director , CMC Team Leader is responsible for developing and leading the ... ideas across the enterprise to drive strategic choices for Global Product Development and Supply. From candidate selection to... R&D project needs . Primary responsibilities of the Director , CMC Team Leader : + Provides leadership… more
- Bristol Myers Squibb (Princeton, NJ)
- …to meet regulatory , quality, medical, and access goals + Serves as a matrix leader to lead , develop, motivate and achieve results through teams, and is the ... . **Position Summary** + CDLs are matrix leaders and managers who lead , develop, motivate and achieve results through teams; demonstrate a commitment to… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , RA Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... Director , RA Labeling Product Leader (1 of...a positive impact on their communities. **Key Responsibilities:** + Lead the development, revision, review, agreement, and maintenance of… more
- Norstella (Trenton, NJ)
- Executive Director , Global CRO & Professional Services Company: Citeline Location: Remote, United States Date Posted: Sep 25, 2024 Employment Type: Full Time Job ... the dots from pipeline to patient. **The Role: Executive Director , Global CRO & Professional Services** The...Global CRO & Professional Services** The Citeline CRO Leader is responsible for leading a team of 3+… more
- Bristol Myers Squibb (Princeton, NJ)
- … , this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory , IT, Audit, Finance and HR to build and ... integrate one global compliance program into...their decisions. + Under the direction of the Senior Director , US and Above Market Medical and Market Access C&E… more
- Merck (North Wales, PA)
- … Investigations in our OGC (Office of General Counsel) organization, the ** Director , Global Investigations** responsibilities include acting as a confidential ... Preferred candidates will have a strong working knowledge of regulatory and compliance laws, including the US Foreign Corruption...who will provide support for investigations led by the Director as well as lead certain investigations… more
- Bristol Myers Squibb (Princeton, NJ)
- …real estate related compliance to all applicable company protocols, practices, procedures and regulatory requirements + Direct and Lead the Approval Process for ... Strategies and Services with the goals and objectives of key stakeholders + ** Global Real Estate Portfolio Management** + Assist in leading the management and… more