- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development ... pertain primarily to marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in collaboration with Head, … more
- Bausch Health (Bridgewater, NJ)
- …and regulatory agency guidance. **KEY ACTIVITIES/RESPONSIBILITIES:** + Manages or represents Regulatory Affairs on the promotional review committees for ... interprets new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review committees and… more
- Bristol Myers Squibb (Madison, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ... risk assessment and mitigation strategies to Commercial Teams, Medical Affairs , Public Affairs , Value Access and Payment,...(MS, PhD, PharmD, JD) + Minimum of 3-5 years Regulatory promotional review or related 5 to… more
- Bausch Health (Philadelphia, PA)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory ...and the ability to see business drivers outside of regulatory affairs + Working knowledge of the… 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 ... or more direct reports. You will represent the commercial regulatory perspective at and chair high-volume Promotional ...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… 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 ... project updates, risks and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory Affairs and Senior… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a...regulatory input and evaluation as part of a promotional review committee. **_This position can be located in… 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 ...leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising… more
- Boehringer Ingelheim (Ridgefield, CT)
- …to five (3-5) years of experience in the pharmaceutical industry with experience in Regulatory Affairs . + Specific experience in regulatory advertising and ... product labeling. Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications. Review scientific exchange… 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 ... of regulatory submissions. + Serves as a regulatory expert for labeling and promotional materials...direction, manage activities, and participate in development plans with Regulatory Affairs Staff. + Effectively deploys appropriate… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …for the clinical research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the ... Job Title Senior Director , Clinical Development & Medical Affairs ...Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device… more
- AbbVie (Mettawa, IL)
- …and promotional materials for assigned therapeutic area(s) within Medical Affairs . Provides timely and accurate reviews of promotional materials in ... regulatory , etc.) as they relate to on-going medical affairs projects. + May assist as consultant and liaison...therapeutic area required. + Good understanding of legal and regulatory guidelines (eg knowledge of OPDP promotional … more
- AbbVie (Mettawa, IL)
- …strategic and operational leadership into global oncology pipeline related medical affairs activities including but not limited to; medical and scientific strategies ... within the pipeline and strategic governance frameworks. + Initiates medical affairs activities, generation and dissemination of data supporting the overall pipeline… more
- AbbVie (Mettawa, IL)
- …and promotional materials for assigned therapeutic area(s) within Medical Affairs . Provides timely and accurate reviews of promotional materials in ... activities with internal stakeholders (eg, commercial, clinical operations, market access, regulatory ) as they relate to on-going medical affairs projects.… more
- AbbVie (Irvine, CA)
- …Follow Allergan Aesthetics on LinkedIn. Job Description Purpose: The Scientific Director , Medical Affairs provides specialist medical and scientific strategic ... medical input into core brand (product) strategies, and to support medical affairs , marketing activities ( promotional material generation and product launches)… more
- AbbVie (Florham Park, NJ)
- …can sit in our Lake County, IL or Madison, NJ offices. The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and ... scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; evidence generation of… more
- AbbVie (Mettawa, IL)
- …with those requirements. Serves as the scientific team interface for key regulatory discussions. Drives medical affairs activities and generation and ... specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions; generation of… more
- Unilever (El Segundo, CA)
- …of health and wellness for all. We're excited to expand our team with a Sr. Director , Scientific Affairs . Come join us! **About the role:** Liquid IV is looking ... thrives in a fast-paced environment to join the scientific affairs team as Sr. Director , Scientific ...as a key scientific liaison in claims generation and regulatory review process. + Develop and implement policies &… more
- Philips (San Diego, CA)
- …body audits. Implements internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will ... Recommends strategies for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems and assists… more
- AbbVie (Florham Park, NJ)
- …scientific, strategic and operational leadership and expertise into core medical affairs activities such as: generation of clinical and scientific data) (enhancing ... and benefit/risk. Works closely with cross-functional medical partners to support medical affairs activities that advance the appropriate and safe use of our… more