- 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
- 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
- Pfizer (Collegeville, PA)
- …with other Regulatory Role(s) (ie regional EM or US lead and/or Global Regulatory Lead for other programs), Project(s) assigned can be in development ... for a Director to join our vaccines Global Regulatory Science team as a US...as regulatory representative to Global Regulatory Strategy Team (GRST). * Lead and… 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
- 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 (Horsham, PA)
- …- 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Global Labeling Product Leader (1 of 2) in ... 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
- Vanguard (Malvern, PA)
- …providing exceptional, high-value business partnership and compliance support. As a trusted leader , the Compliance Director , Regulatory Exam Response will ... Compliance Director , Regulatory Exam Response Advocate for...with purpose - and that's how we've become a global market leader . Here, we grow by… more
- Publicis Groupe (Philadelphia, PA)
- …www.twitter.com/digitas_health **Job Description** Within Digitas Health, the Vice President, Director , Regulatory Review will provide advice to creative, ... regulatory review by Digitas Health's external clients. The Vice President, Director , Regulatory Review supports teams with managing their clients' review… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** Lead medical writing of clinical regulatory documents for various types of regulatory filings, including but not limited ... to coordinate routinely with leadership in the Product Registration ( Regulatory Liaison) organization, Medical/Clinical/Safety organizations (with CRO), vendor oversight… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead + Recommend strategies and labeling language for ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where...the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that… more
- Merck (West Point, PA)
- …creative conflict resolution and problem-solving skill. + Strong knowledge of global regulatory guidelines and cGMP principles. + Demonstrated experience ... seeking a highly motivated individual for the role of Director , Tech Transfer Group Leader in Large...and escalations. + Required to comply with our Company Global and regulatory requirements and execute current… more
- CBRE (Philadelphia, PA)
- HSE Senior Director - Retail & Enterprise Global Services/Infrastructure, Defense and Public Enterprise Sectors Job ID 151325 Posted 15-Feb-2024 Service line GWS ... common cross functional HSE platform. + Collaborate with the Global Transition Platform Lead regarding HSE aspects...estate solutions. Each client is entrusted with a dedicated leader and is supported by regional and global… more
- J&J Family of Companies (Spring House, PA)
- …Clinical Development and Clinical Pharmacology experience is preferred. + Knowledge of global regulatory requirements, ICH, GCP and clinical trial terminology is ... Associate Director , Translational Clinical Medical Lead Translational...relevant stakeholders at the CDT. The TCML collaborates with Global Development Operations (GDO) and the entire Trial Team… more