- 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 (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
- 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
- Sanofi Group (Bridgewater, NJ)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in ... prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs ( US RA AdPromo)...to the promotion of prescription drugs in the Uniteed States + The individual will require strong verbal and… 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
- 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 ... diseases and immune disorders. **Summary** Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic… 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 plan… 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
- 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
- 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 ...arrangement can also be considered._** Sanofi Inc. and its US affiliates are Equal Opportunity and Affirmative Action employers… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …with life-threatening diseases. We have an exciting opportunity within US Medical Affairs for an Associate Director in our Patient Access and Quality of ... PAQ Virology. The Associate Director of Medical Affairs - PAQ Virology will support the US...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … (CDMA) Requisition JR000014103 Senior Director , Clinical Development & Medical Affairs (CDMA) (Open) Location US Specialty Brand Headquarters - USA501 ... Additional Locations Bridgewater, NJ Job Description The Senior Director , Clinical Development Medical Affairs (CDMA) drives...aspects of registration activities with a working knowledge of regulatory affairs , in the development of the… more
- AbbVie (Florham Park, NJ)
- …*Position can sit in our Lake County, IL or Madison, NJ offices. The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical ... our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … & Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to our current portfolio and robust ... Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states and DC, with a focus… more
- Randstad US (Bridgewater, NJ)
- … regulatory experience as a: Consultant, Director , Global Reg Affairs Specialist skills: Biology, Regulatory Affairs Strategy Equal Opportunity ... usa- regulatory affairs specialist project lead i...responsibilities: + This role will require direct experience in US FDA Advisory Committee (ADCOM) Preparation. Experience in Immunology… more
- Adecco US, Inc. (Bridgewater, NJ)
- …Nice to Have/ Preferred: * Previous regulatory experience as a: Consultant, Director , Global Reg Affairs Specialist **Pay Details:** $88.00 to $89.22 per ... Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical...eligibility criteria This role will require direct experience in US FDA Advisory Committee (ADCOM) Preparation. Experience in Immunology… more
- AbbVie (Florham Park, NJ)
- …our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and ... scientific, strategic and operational leadership and expertise into core medical affairs activities such as: generation of clinical and scientific data) (enhancing… more
- Bausch Health (Bridgewater, NJ)
- …effective aesthetic care options to consumers and physicians alike. The Professional Affairs lead is accountable for the designing & executing Solta's education ... with outstanding collaboration and teamwork with key partners such as, Medical Affairs , Marketing, Sales, Compliance, Quality, KOLs, etc. This role is responsible… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... collecting, analyzing, synthesizing and communicating intelligence relating to the US regulatory framework. ** Regulatory Policy**...Qualifications** + 7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years… more