- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Development, may be called upon to ... unmet medical needs in North American markets. In the United States , MTPA launched rare disease treatments...to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... unmet medical needs in North American markets. In the United States , MTPA launched rare disease treatments...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… 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
- 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
- Bausch Health (Bridgewater, NJ)
- …and regulatory agency guidance. Responsibilities: + Manages or represents Regulatory Affairs on the promotional review committees for prescription products ... 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people...new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review… more
- Merck (Rahway, NJ)
- **Job Description** **Position Title** - Principal Scientist **Department** - Global Regulatory Affairs and Clinical Safety - Vaccine & Infectious Disease ... **Brief Description of Position** The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Bausch Health (Bridgewater, NJ)
- …**KEY ACTIVITIES/** **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead and grow individuals on the Regulatory ... standards and other best practices guidelines + Identify opportunities to streamline Regulatory Affairs processes to promote operational excellence + Provide… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people...promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... objectives. This group also represents Gilead's commercial activities to US regulatory agencies. You will manage the...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …within the Inflammation TA. You will work closely with the Inflammation Fibrosis Regulatory Affairs (RA) Franchise Lead, Regional Regulatory Liaisons and ... regulatory strategy. + Provide strategic guidance as the Regulatory Affairs Inflammation subject matter expert on...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan… more
- Bristol Myers Squibb (Madison, NJ)
- …BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that... . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Merck (Rahway, NJ)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of 8 years of relevant … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with respect to impact development programs. Additionally, this position interacts with Regulatory Affairs (RA) team members, cross-functional team members, FDA ... therapeutic area direction and corporate objectives. Serve as Global Regulatory Lead or US regulatory ...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience + Managerial experience preferred… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA submission experience + ... and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …goals, both at work and in their personal lives. Read more: careers.bms.com/working-with- us . The GRS-CMC organization provides regulatory expertise related to ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that...to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for… more
- Merck (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... performance against metric targets. + Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own. + Lead… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more