- 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 (Rockville, MD)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... **Job Description** Our Regulatory Affairs team bring new medical...but are not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area Lead. +… 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
- 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
- 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
- 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
- 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 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...you if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development… 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
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. **Senior Advisor/ Director , Global Regulatory Affairs - CMC, Small Molecules** At Eli ... for people around the world. Lilly is looking for regulatory CMC scientists to join us in...who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs … more
- AbbVie (Irvine, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director of Regulatory Affairs - Soft Tissue Fillers MPS ... including but not limited to US , EU, US , Japan, and China. Supports regulatory intelligence...regulatory interactions with Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory… more
- ADM (Kennesaw, GA)
- … H&W - Kennesaw, GA **Department/Function:** Health, Safety & Environment **Job Description:** ** Director Regulatory & Scientific Affairs , Health & Wellness ... This is an Exempt level position. **Position Summary:** The Director Regulatory & Scientific Affairs ,...+ Minimum of 5 years of experience in a regulatory role, in US within the dietary… 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
- Kellanova (Chicago, IL)
- As a Director of Wellbeing & Regulatory Affairs (Salty, Portable Wholesome Snacks & Customer Activation), you will drive differentiation and enable share ... This will be achieved by providing strategic wellbeing & regulatory thought leadership to Kellanova category teams. You will...reviewed by a real recruiter, so it may take us a few weeks to get back with you… more