- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs II Date: May 19, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: ... to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs II will...how systems are integrated to support day to day regulatory and submission publishing business processes with… 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: Teva ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC...the development teams. ⦁ Develop and communicate effective CMC regulatory strategies for development and post marketing submission… 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...of commercialization. + Leads the execution of global CMC regulatory plans, including overseeing the submission preparation… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Pleasanton, CA, USA * Princeton, NJ, USA Req #374 Thursday, May 30, 2024 Looking for a chance to make a ... post marketing and/or development regulatory activities under the direction of Regulatory Affairs management. The incumbent plans, directs and executes the … more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Senior Director supporting...+ Ensure consistency of evidence-based global product communication (eg, regulatory submission documents) + Monitor and assess… 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 ... and timelines for submission of various regulatory licensing activities for...and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory … more
- J&J Family of Companies (Raritan, NJ)
- Director , Regulatory Affairs - 2406188412W **Description** **Employer:** Janssen Research & Development, LLC **Job Title:** Director , Regulatory ... years of progressive, post-baccalaureate experience in the job offered or in a Director , Regulatory Affairs -related occupation. This job posting is… 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...have an external business partner. + Coordinates the preparation, submission and follow-up contact with regulatory agencies… 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
- 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...(such as US FDA and EU IVDR). + Provides regulatory strategy relative to premarket submission , IVD… 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 ,...actions as applicable. + Own the preparation, review and submission of regulatory dossiers and applications for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years relevant pharmaceutical experience including experience within Regulatory Affairs + Understanding of scientific content and complexities and ... to patients. Responsibilities + **CDx development:** Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan… 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 ... who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs ...critical review of molecule specific CMC development strategies and submission content. + Makes decisions on CMC regulatory… more
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the oncology ... and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly...regulatory compliance and completeness. + Responsible for developing submission strategy for assigned projects and specific areas of… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …+ As appropriate, manage the performance review, hiring and firing process for Regulatory Affairs professionals under his/her direction. + Lead by providing the ... provide direction, manage activities, and participate in development plans with Regulatory Affairs Staff. + Effectively deploys appropriate management 'standard… more
- AbbVie (Irvine, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director of Regulatory Affairs - Soft Tissue Fillers MPS ... regulatory interactions with Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory...and desired experience in the CE Marking process, global regulatory strategy, and regulatory submission … more
- AbbVie (Irvine, CA)
- …the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory policy, intelligence ... Follow Allergan Aesthetics on LinkedIn. Job Description The Associate Director of Regulatory Innovation supports regulatory...preferred. + Experience in the CE Marking process, global regulatory strategy, and regulatory submission … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA submission experience + Experience ... and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Sanofi Group (Bridgewater, NJ)
- …and Capabilities** + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for ... The Associate Director RA serves as the regulatory ...through review and approval, up to and including APLB submission . + Provide a leadership role on the review… more
- J&J Family of Companies (Warsaw, IN)
- …Regulatory Affairs Specialist will coordinate the day-to-day Regulatory Affairs operations as advised by the Associate Director related to New Product ... Regulatory Affairs Specialist II (DePuy Synthes)...manage multiple projects simultaneously under fixed timelines, * Interprets regulatory requirements and coordinates aspects of submission … more