- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: May 15, 2024 Location: West Chester, United States , Pennsylvania, 19380 Company: ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC...ICH Regulatory guidelines ⦁ Experience with eCTD regulatory filings ⦁ Knowledge of US and… more
- Merck (North Wales, PA)
- **Job Description** The Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their ... Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. +… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States , Pennsylvania, 19380 ... with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will...and approval in more than one key region (EU, US , Canada, Japan) as well as life cycle management… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs II Date: Apr 20, 2024 Location: West Chester, United States , Pennsylvania, 19380 Company: Teva Pharmaceuticals ... to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs II will...you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout… more
- Taiho Oncology (Pleasanton, CA)
- Sr. Director , Regulatory Affairs Strategy...Knowledge, Skills, and Abilities: + Extensive previous experience in Regulatory Affairs (both US and ... and Asia. For assigned projects and products, the Senior Director , Regulatory Affairs Strategy is...Substantial knowledge of and experience interacting and negotiating with US , EU and other regulatory agencies. +… more
- Teva Pharmaceuticals (West Chester, PA)
- Director , Regulatory Affairs , Strategy - Innovative Medicine (West Chester, PA or Remote) Date: Apr 29, 2024 Location: West Chester, United States , ... people to make a difference with. **The opportunity** The Director , Global Regulatory Affairs , is...in West Chester, PA or Remote (anywhere in the US ) **RELOCATION ASSISTANCE AND WORK VISA SPONSORSHIP IS AVAILABLE**… 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 ... It takes the imagination and passion of all of us -from design and engineering to the manufacturing and marketing...and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory … more
- Teva Pharmaceuticals (West Chester, PA)
- Director Regulatory Affairs - Submission Management - West Chester, PA Date: Apr 20, 2024 Location: West Chester, United States , Pennsylvania, 19380 ... Medicine Dossier Project Manager, a key member of Global Regulatory Affairs , will be responsible to develop...regulatory project plans for major global dossiers. The Director that fills this highly visible role will work… more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… more
- Baystate Health (Springfield, MA)
- Under the direction of the Chief Quality Officer, the Senior Director , Regulatory Affairs directs the strategic management and planning for the Joint ... throughout Baystate Health, including all licensed sites. The Senior Director , Regulatory Affairs develops a...envision purpose, engage people and execute productively, thus allowing us to fulfill our mission and achieve our vision… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... programs in various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams (commercial, clinical… more
- AbbVie (Lake Bluff, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs , Strategic Global Labeling - Combination ... Target Product Label (TPL), Company Core Data Sheets (CCDS), US Package Insert (USPI), European Summary of Product Characteristics...trends and best practices in combination product and device regulatory affairs , review and comment on changing… more
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC...Abilities: + Fifteen years' previous CMC drug development and regulatory experience (both US and EU preferably) ... organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more...and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The 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...you if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The 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...you if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Abbott (Abbott Park, IL)
- … data is maintained in electronic systems. + Depending on specific role, the Associate Director Regulatory Affairs may be involved in various regulatory ... generic medicines. Our 114,000 colleagues serve people in more than 160 countries. **Associate Director of Regulatory Affairs ** **About Abbott** Abbott is a… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …to marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in collaboration with Head, Regulatory ... unmet medical needs in North American markets. In the United States , MTPA launched rare diseases treatments...and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** ... The Sr Director , CMC Regulatory Affairs for Small Molecules is responsible...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs , Precision Medicine you will ... need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- AbbVie (North Chicago, IL)
- …defines quality objectives, both strategic and applicable regulatory requirements. Director , Safety, Regulatory and Medical Affairs Quality Standards ... responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs...assurance excellence mindset. The role reports to the Senior Director of Safety, Vigilance and Medical Affairs … more