- J&J Family of Companies (Columbus, OH)
- Associate Director, CMC Regulatory Affairs + Job titleAssociate Director, CMC Regulatory Affairs + FunctionDiscovery & Pre- Clinical / Clinical ... Share **Description** Johnson & Johnson is recruiting for an Associate Director, CMC Regulatory Affairs . This… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing and ... and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. **Sr. Associate , CMC Regulatory Affairs - Biologics** Gilead Sciences is ... a full-time employment role in the capacity of Senior Associate in Gilead's Regulatory Affairs ...and company policies and procedures. + Responsible for routine clinical and commercial labeling approvals and changes, protocol reviews,… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC...Provide guidance for resource and development planning + Approve regulatory filing strategies based upon proposed preclinical, clinical… more
- Kelly Services (Irvine, CA)
- ** Regulatory Affairs Specialist** The Regulatory...the Kelly Talent Community. Why Kelly (R) Science & Clinical ? Kelly Science & Clinical is your ... Affairs Specialist II, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with US and… more
- Randstad US (Newbury Park, CA)
- regulatory affairs senior associate . +...GED and 8 years of experience skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, ... Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions, ICH Regulations Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual… more
- University of Michigan (Ann Arbor, MI)
- Chief Pharmacy Officer/ Associate Dean for Clinical Affairs Apply Now **Job Summary** + Reporting jointly to the Chief Operating Officer of Pharmacy at ... CPO will also serve as a faculty member and Associate Dean for Clinical Affairs ...+ Ensure compliance with all local, state and national regulatory bodies. + Oversee and ensure systems for the… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director, Analytical Regulatory Sciences, Systems & Operations in ... is a site based position located in Foster City, CA_** The Associate Director, Analytical Regulatory Science, collaborates with product development,… more
- Organon & Co. (Plymouth Meeting, PA)
- …Organon Regulatory Chemistry, Manufacturing and Controls New Products, the Associate Principal Scientist ( Associate Director) is responsible for ... Regulatory Chemistry, Manufacturing and Controls (CMC) aspects of clinical phase through market product registration for the assigned biological/ biosimilar/small… more
- Organon & Co. (Plymouth Meeting, PA)
- …**The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist ( Associate ... for Regulatory Chemistry Manufacturing & Controls (CMC) aspects of clinical phase through market product registration for the assigned portfolio of small… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Merck (Boston, MA)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented...labeling and obtain shortest time to approval by global regulatory agencies. + Reports to Associate Vice… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …leadership to business partners, the Associate Director of Process Excellence Regulatory Affairs , and execute regulatory strategies and objectives for ... **Job Description Summary** The Sr. Director, Regulatory Affairs is the ranking ... issues for staff and for business stakeholders (eg, Clinical , R&D., Marketing) + In conjunction with RA business… more
- Merck (North Wales, PA)
- …Director/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to...promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates… more
- Merck (Boston, MA)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented...to facilitate initial approval by agencies for conduct of clinical trials + Participate in regulatory due… more
- Amgen (Los Angeles, CA)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional Regulatory Lead - Oncology** ... do Let's do this. Let's change the world. The Regulatory Affairs Senior Manager at Amgen ensures... regulatory strategies. **Responsibilities:** + Implement the US regulatory plan and obtain and maintain Clinical … more
- Unilever (San Francisco, CA)
- THE ROLE: SCIENTIFIC AFFAIRS ASSOCIATE The Scientific Affairs Associate will be instrumental in supporting the development and documentation of ... guidelines and legal standards. + Collaborate with the R&D, Regulatory Affairs , Legal, and Brand teams to...is preferred. + Strong understanding of scientific research methods, clinical trial design, and regulatory requirements. +… more
- AbbVie (North Chicago, IL)
- …responses. Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, ... indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of… more
- AbbVie (Mettawa, IL)
- …(promotional material generation and product launches) and market access. Collaborates with clinical development on Medical Affairs support of priority trials. ... Affairs initiatives for the target indication. + Develops and executes Medical Affairs support of priority clinical development trials. + Contributes to the… more
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