- Merck & Co. (North Wales, PA)
- …Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comment-Propose ... in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- DivIHN Integration Inc (Lake Forest, IL)
- …following opportunity, please contact one of our Talent Specialists Rashi at ### Title: Regulatory Affairs Associate Jr Location: Lake Forest, IL Duration: 7 ... Months Description Exempt/Non Exempt: Non exemptYears. Duties: Manager regulatory submissions ot ensure timely regulatory approval of medical devices.… more
- J&J Family of Companies (Irvine, CA)
- Associate Director, Regulatory Affairs ...Manages and reviews the preparation of US and EU regulatory submissions , including, but not limited to ... of Johnson & Johnson MedTech, is recruiting for an ** Associate Director, Regulatory Affairs ** ....prepare appropriate regulatory strategies. * Communicate with Regulatory Agencies regarding strategies and submissions and… more
- System One (Florham Park, NJ)
- Position: CONTRACTOR -- US Regulatory Affairs - GDP, RA, Associate Location: Remote (East or Central Time Zone) Contract: 12mns Pay Rate: 25/hr - 35/hr This ... Regulatory Affairs preferred. + Working knowledge and experience in regulatory submissions and product life cycle management. + Knowledge of drug… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director, Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... format and information in the development and execution of regulatory submissions . + Ensures accuracy of Clinical...and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory … more
- J&J Family of Companies (Columbus, OH)
- Associate Director, Regulatory Affairs - 2406166277W **Description** Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of ... Companies, is recruiting for an Associate Director, Regulatory Affairs . This...technology assessments, payor demands). + Own the preparation of regulatory dossiers for submissions to US and… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director, Regulatory Affairs - West Chester, PA Date: Mar 26, 2024 Location: West Chester, United States, 1938 Company: Teva Pharmaceuticals Job ... difference with. **How you'll spend your day** As the Associate Director, Regulatory Affairs you...regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs… more
- Abbott (St. Paul, MN)
- …catheters and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Associate Director Regulatory Affairs ** will work on-site at ... Vascular Division. As a manager, the function of an Associate Director Regulatory Affairs is...regulatory product approvals. + Directs staff in implementing regulatory strategy and preparing regulatory submissions… more
- ADM (Kennesaw, GA)
- **83604BR** **Job Title:** Senior Regulatory Affairs Associate - Kennesaw, GA **Department/Function:** Legal, Compliance, Regulatory Affairs , ... Corporate Security **Job Description:** **Senior Regulatory Affairs Associate - Kennesaw, GA** This is a full-time, exempt position. **Job Purpose:** + The… more
- Bristol Myers Squibb (Madison, NJ)
- …. **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert ... risk assessment and mitigation strategies to Commercial Teams, Medical Affairs , Public Affairs , Value Access and Payment,...Branch advisory submissions and sub part e/h submissions . + Ensure full regulatory compliance of… more
- Endo International (Woodcliff Lake, NJ)
- …inclusive workplace, and we are looking for talented individuals to join our team. The Regulatory Affairs Labeling Senior Associate is a key member of the ... report directly to the Regulatory Affairs Labeling Director. The Regulatory Labeling Senior Associate will be responsible for the development/revision of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... biologic products. + Significant experience leading development and execution of regulatory submissions of promotional materials for marketed prescription drug… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …compile, submit, and maintain Regulatory Submission Documentation for global regulatory submissions to global Health Agencies in electronic and/or paper ... Annual Reports and other duties as needed. **Primary responsibilities for the Regulatory Affairs Specialist role:** + Manages dossier compilation for product… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Regulatory Affairs , Strategic Global Labeling - ... with Global industry trends and best practices in combination product and device regulatory affairs , review and comment on changing regulation and guidance. +… more
- AbbVie (Irvine, CA)
- …life cycle management of the medical product. + Authors and s upports regulatory submissions , regulatory operations, change control, lifecycle management, ... the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory policy, intelligence… more
- AbbVie (North Chicago, IL)
- …regulatory requirements and guidelines. + Manages the preparation and review of regulatory submissions to assure effective presentation of data, complete and ... goals. Possess and leverage broad industry knowledge. Coordinates and prepares submissions in line with Health Authority regulatory requirements and… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific ... for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes their own… more
- Fresenius Medical Center (Waltham, MA)
- …compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison ... representation and direction in managing information from/to other departments regarding regulatory submissions . + Support product development teams by… more
- Dorsey & Whitney LLP (Boise, ID)
- …acquisitions, joint ventures, and other project development and transactional matters in our Regulatory Affairs Practice Group. This associate will have the ... Regulatory Affairs (Natural Resources, Energy and Real Estate) Associate (#857) Dorsey & Whitney LLP is seeking an associate with at least three years of… more
