- Merck & Co. (North Wales, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... Brochures before release from our company to external agencies and investigators.Represents Global Regulatory Affairs (GR) within internal committees to… more
- Merck & Co. (North Wales, PA)
- …medicines that help people with cancer across the globe.The Regional Associate Director of Medical Affairs - Gastrointestinal Cancer (RADMA) position is ... with the Upper GI and Lower GI US Regional Director of Medical Affairs (RDMAs) and partner...to provide region-specific strategic input into the development of global medical affairs plans -Collaborates across various… more
- Merck & Co. (North Wales, PA)
- …Document for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the… more
- Merck & Co. (North Wales, PA)
- …position operates under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance ... forecasting and analytical support to our Research & Development Division, Global Regulatory Affairs & Clinical Safety (GRACS), and QA organizations.Forecast… more
- Merck & Co. (North Wales, PA)
- …resources to address the opportunities.Collaborating with Global Medical and Scientific Affairs (GMSA), US, Senior Director of Medical Affairs (SDMA), ... Job DescriptionJob Description:The Associate Director , Marketing, HPV Scientific Strategy plays a critical...for a One Company approach.Collaborating with Program Leads, Medical Affairs and Global Expert Management & Strategy… more
- Merck & Co. (North Wales, PA)
- …studies;Work 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...and dedicated colleagues while developing and expanding your career.-- Director (Principal Scientist) has primary responsibility for the planning… more
- Merck (Upper Gwynedd, PA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- J&J Family of Companies (Titusville, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader located in New Jersey or Pennsylvania. At Johnson & ... exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on… more
- Merck (North Wales, PA)
- …Description** We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset ... and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine + Works… more
- Merck (North Wales, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... release from our company to external agencies and investigators. + Represents Global Regulatory Affairs (GR) within internal committees to provide … 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)
- …medicines that help people with cancer across the globe. The Regional Associate Director of Medical Affairs - Gastrointestinal Cancer (RADMA) position is a ... with the Upper GI and Lower GI US Regional Director of Medical Affairs (RDMAs) and partner...to provide region-specific strategic input into the development of global medical affairs plans + Collaborates across… more
- Organon & Co. (Plymouth Meeting, PA)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage ... high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and… more
- Organon & Co. (Plymouth Meeting, PA)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage ... Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products,...participating in Agency meetings on CMC topics, and executing global initial marketing applications with a line of sight… 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
- Organon & Co. (Plymouth Meeting, PA)
- …regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation ... **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry, Manufacturing and...to assess acceptability and identify potential risks. + Execute global regulatory strategies by leading the development,… more
- Merck (North Wales, PA)
- …for projects of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... **Job Description** Under general supervision of an Executive Director /Senior Director , the Principal Scientist /...Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to… more
- Merck (North Wales, PA)
- …position operates under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance ... + Provide financial planning, forecasting and analytical support to ourResearch&DevelopmentDivision, Global Regulatory Affairs & Clinical Safety (GRACS),… more
- Merck (Trenton, NJ)
- …up with the latest regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and ensure submission readiness in all ... **Job Description** The Executive Director , Device Quality & Regulatory will...emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as… 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
