- Merck (Philadelphia, PA)
- …**Associate Director , Portfolio & Program Management (PPM)** The Associate Director in Regulatory Planning and Publishing works closely with various ... planning, execution, and management of activities that deliver high quality and timely regulatory and safety submissions for approval. The incumbent will be… more
- System One (Malvern, PA)
- Job Title: Director of Regulatory and Medical Affairs Location: Malvern, PA Type: Direct Hire Essential Duties/Responsibilities: + Manage Regulatory and ... Medical Affairs SOPs to ensure full compliance with global regulatory requirements. + Maintain current knowledge of changes to...get work done more efficiently and economically, without compromising quality . System One not only serves as a valued… more
- Charles River Laboratories (Wayne, PA)
- …responsibilities. ⦁ Assume a lead role in the development and presentation of regulatory training for Quality Assurance and operations staff. ⦁ Manage ... Affairs and Compliance projects and programs. ⦁ Participate in Corporate Quality Meetings, Regulatory Affairs and Compliance meetings, intranet communications,… more
- United Therapeutics (Harrisburg, PA)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... or pharma regulatory experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area of study or 7+ years of biologic or… more
- Organon & Co. (Plymouth Meeting, PA)
- …interfaces with local country affiliate colleagues to support timely and quality regulatory submissions and approvals globally. **Required Education, Experience ... on assigned products for all internal and external stakeholders to ensure timely regulatory submissions, quality and compliant labeling documents, and to support… more
- J&J Family of Companies (Spring House, PA)
- …We are searching for the best talent for an **Associate Director , Regulatory Medical Writing** within our Integrated Data Analytics ... or more of our therapeutic areas within the X-TA Regulatory Medical Writing area. This position is open globally...summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types… more
- Merck (North Wales, PA)
- …product life cycle. + Oversee the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. ... **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in...robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network on the leading… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… more
- Merck (Harrisburg, PA)
- **Job Description** We are seeking a dynamic and experienced Quality & Compliance Director to lead GMP compliance across our global network of internal and ... outcomes to identify trends, drive improvements, and report findings to senior quality and management councils. + ** Regulatory Consultation:** Offers proactive… more
- Merck (West Point, PA)
- …tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our West ... Patients on time, every time, across the globe. The Quality Compliance Director will be a core...the quality oversight and management of the Quality team overseeing Regulatory Inspections, Site Internal… more