- Catalent (Philadelphia, PA)
- …verbal and written. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function...delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality… more
- Merck & Co. (North Wales, PA)
- …Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting ... Job Description Position Description: Associate Director , Regulatory Affairs Liaison- Vaccines and...Global Liaison.Participates as an active member on the Global Regulatory Team. They will attend cross-functional… more
- Merck & Co. (North Wales, PA)
- …development, including a communication cascade plan in conjunction with Director of Commercial Operations (DCO)Contracting point(s).Collaborate with brand teams to ... understand priorities and synergies with commercial engagement.- Lead the development of resources through the promotional approval process; requires collaboration… more
- Merck & Co. (North Wales, PA)
- … Global Medical and Scientific Affairs (GMSA) that reports directly to the Director , Medical Operations, Innovation and Emerging Projects Lead .The AD, IEP is ... Job DescriptionRole SummaryThe Associate Director , Medical Operations, Innovation and Emerging Projects (AD,...IEP participates in several of the following core GMSA global initiatives and assumes varying degrees of project leadership:… more
- Merck & Co. (North Wales, PA)
- …input/output requirements, including but not limited to chemical, physical, or performance specifications. Lead and manage development of Global Design file (GDF) ... and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for independent… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, we ... cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May Be… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we ... an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Project Management and Strategic Planning - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory ... Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management...and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-… more
- J&J Family of Companies (Titusville, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , ... 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
- Pfizer (Collegeville, PA)
- …Team(s). As a Director , Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from ... Project(s)/Product(s) teams. + In partnership with the Project/Product Team Leader (eg MTL, GCMTL, RPL etc.), accountable for the...direct regulatory experience, preferably including as a Global Regulatory Lead and leading… more
- Bristol Myers Squibb (Trenton, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy within a development team (DT). ... + Serve as team lead or co- lead of marketing application submission...+ Ensure global development plans will meet global regulatory requirements by soliciting and integrating… more
- Bristol Myers Squibb (Trenton, 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
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and ... Senior Director Regulatory Affairs CMC (Biologic Products)...major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for… more
- Organon & Co. (Plymouth Meeting, PA)
- …**The Position** The successful candidate will lead a group of Global Regulatory Leads (GRLs), who are responsible for development and implementation ... products and portfolio. + Guide and coach GRLs in creating and implementing global regulatory strategy for registration, maintenance and market expansion of… more
- Teva Pharmaceuticals (West Chester, PA)
- …to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. The Director will foster relationships with opinion ... (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input...Oversees the preparation of documents for IND/NDA and other regulatory documents + May lead an NDA… more
- J&J Family of Companies (Spring House, PA)
- Global Medical Affairs Leader , Director...clinical development within the Immunology TA. The GMAL will lead the Global Medical Affairs Team and ... Global Medical Affairs, is recruiting for a Global Medical Affairs Leader (GMAL), Director...areas. Be an active member of the CDT and lead a Global Medical Affairs Team consisting… more
- Pfizer (Collegeville, PA)
- …on doing better for Pfizer's patients and healthcare. **ROLE RESPONSIBILITIES** + Proactively lead the development of the Global HTA evidence generation strategy ... + Lead and supervise the design and execution of global HEOR studies (eg, network meta-analyses, non-interventional studies) from concept through publication,… more
- J&J Family of Companies (Horsham, PA)
- …2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Global Labeling Product Leader in Raritan, NJ; ... Associate Director , Global Labeling Product Leader...a positive impact on their communities. **Key Responsibilities:** + Lead the development, revision, review, agreement, and maintenance of… more
- Merck (North Wales, PA)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or... Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - Remote OR...will be responsible for acting as and supporting the Global Regulatory Lead (GRL) in ... strategy for biosimilar (BioS) projects. You will be accountable to lead and/or support the Global Regulatory Affairs (GRA) Team for assigned projects to… more
