- 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
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy...Skills, and Abilities: + 9-11 years of experience in US Regulatory Affairs in development, ... post marketing and/or development regulatory activities under the direction of Regulatory Affairs management. The incumbent plans, directs and executes the … 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
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine knowledge of… 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
- Merck (North Wales, PA)
- **Job Description** **Position Description:** **Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease** The Regulatory ... the Vaccine and Infectious Disease (VID) therapeutic area as part of a regulatory team. They will have excellent communication and collaboration skills and will work… more
- Google (San Francisco, CA)
- …constructive engagement with governments and regulators while mitigating risk. As Senior Director , Regulatory Affairs , Content Advisory Global Lead, you'll ... attention to detail with the ability to be action-oriented. Regulatory Affairs helps the company innovate responsibly...you'll oversee teams covering specific regions and functions. The US base salary range for this full-time position is… 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
- Lilly (IN)
- …and one of the most common of all sensory disorders. **Responsibilities:** The Sr. Director , Regulatory Affairs will be responsible for directing ... (eCTD) submissions + Understanding of GxP, as well as US and international regulations and regulatory filings...well as US and international regulations and regulatory filings + Excellent document drafting, editing, and proofreading… 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 (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)
- … Affairs H&W NA **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
- New York State Energy Research and Development Aut (New York, NY)
- …passion to work in a fast-paced environment on the cutting edge of energy policy. The Director , Legal and Regulatory Affairs will report directly to the NY ... Bank's Managing Director , Head of Legal and Regulatory Affairs and be charged with anticipating...or university and admitted to practice law in a US jurisdiction for at least eight years. If bar… 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