- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, ... submissions, as appropriate, and corresponding therapeutic dossiers.Interacting with global regulatory authorities and diagnostic partners to determine… more
- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Merck & Co. (North Wales, PA)
- …including the related SOPs and Execution resources. The incumbent is accountable to Sr. Director of Business Process and Systems with input from VP, CSRM as needed, ... contributing functional areas and process governance committees. Works with Sr. Director for Business Process and Systems, -CSRM to develop and implement… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director /Senior Director ... Document for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change… more
- Merck & Co. (North Wales, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Job DescriptionOur company is a global health care leader with a diversified portfolio...of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May… more
- Merck (North Wales, PA)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... as appropriate, and corresponding therapeutic dossiers. + Interacting with global regulatory authorities and diagnostic partners to...devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of… more
- Merck (North Wales, PA)
- …The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business ... compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively engages with...+ Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that… more
- J&J Family of Companies (Titusville, NJ)
- …of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of 2) located ... Director , Global Regulatory Leader...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on… more
- Chemours (Wilmington, DE)
- …improvement at a time. Chemours is seeking a ** Director of Regulatory Advocacy** to join our growing **Government Affairs ** team! This position ... **Washington, DC** office. The successful candidate will join Chemours' Global Government Affairs Group with a primary...Group with a primary responsibility for supporting US federal regulatory affairs engagement with the United States… more
- Merck (North Wales, PA)
- …standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... **Job Description** Reports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Merck (North Wales, PA)
- …including the related SOPs and Execution resources. The incumbent is accountable to Sr. Director of Business Process and Systems with input from VP, CSRM as needed, ... contributing functional areas and process governance committees. Works with Sr. Director for Business Process and Systems, CSRM to develop and implement… more
- J&J Family of Companies (Horsham, PA)
- …partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (eg Biostats, GCO, Regulatory Affairs , QA and QC) to ... Medical Director , Gastroenterology Therapeutic Area - Medical Affairs...with other GI team members in the US and Global Medical Affairs Organization, as well as… more
- Kelly Services (Horsham, PA)
- … Affairs Coordinator will help administer the day-to-day Regulatory Affairs operations as directed by the Associate Director related to Product Lifecycle ... Kelly Science and Clinical FSP is currently seeking a Regulatory Affairs Specialist for a long-term engagement...Specialist for a long-term engagement with one of our Global Pharmaceutical clients. This person will join our Kelly… more
- Merck (Trenton, NJ)
- **Job Description** **Health Systems Oncology Medical Affairs Director , US Medical Affairs - NorCal, NV, AZ** The Health Systems Oncology Medical Affairs ... in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also...resource for the HSO MAD Team Lead, HSO Executive Director Medical Affairs , and other members of… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Merck (North Wales, PA)
- **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director /Senior ... for projects of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change… more
- Takeda Pharmaceuticals (Exton, PA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
