- EY (Jericho, NY)
- …we offerThe compensation ranges below are provided in order to comply with United States pay transparency laws. Other geographies will follow their local ... perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and...Public Policy function focuses on the public policy and regulatory issues that affect EY's businesses. Our dialogue with… more
- DivIHN Integration Inc (Chicago, IL)
- …duration with extension potential (up to 3-4 yrs) Primary Job Function: Supports Global Director of Medical and Scientific Affairs to defining medical affairs ... the following responsibilities under the supervision of the Global Director of Medical and Scientific affairs : Functions...to give input on clinical trials. Meet with the regulatory team About us : DivIHN, the 'IT… more
- 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
