- Merck & Co. (North Wales, PA)
- …with FDA's promotional review divisions Office of Promotion and Advertising Review(OPDP)/ Advertising and promotional labeling branch (APLB), including ... Job DescriptionReports to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the… more
- DivIHN Integration Inc (Green Oaks, IL)
- …Principles and requirements of promotion , advertising and labeling ; Domestic and international regulatory guidelines, policies and regulations; Ethical ... one of our Talent Specialists Meghna at ### Rashi at ### Title: Regulatory Affairs Specialist Location: Abbott Park, IL Duration: 7 Months Description Responsible… more
- Sanofi Group (Bridgewater, NJ)
- …the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials. + Develops solutions to complex promotional ... applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices.… more
- Merck (North Wales, PA)
- …with FDA's promotional review divisions Office of Promotion and Advertising Review(OPDP)/ Advertising and promotional labeling branch (APLB), including ... Reports to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate...standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to… more
- Sanofi Group (Cambridge, MA)
- …maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics. Essential ... input into the review and approval of US advertising , promotion , disease-state, market access, and press...in training of sales and marketing personnel on promotional, labeling and advertising regulations. + Participates in… more
- Lundbeck (Deerfield, IL)
- …cross-functional team on key labelling requirements (CMC, Regulatory Operations, US Labeling and Advertising and Promotion , International regulatory ... Director US Regulatory Global Strategic Labelling - Remote Opportunity Requisition...functional governance bodies, such as Safety Committee/Board and US labeling committee. Collaborates with cross functional team to support… more
- Bristol Myers Squibb (Madison, NJ)
- … labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based. + Provide input on process improvement and ... and promotion regulations including guidance(s) + Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness,… more
- Sanofi Group (Cambridge, MA)
- …, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including ... the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling , product defense, and development projects. Serve… more
- Gilead Sciences, Inc. (Foster City, CA)
- …make a direct impact. Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core ... regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex...enforcement actions with regards to advertising and promotion of pharmaceutical products. + Serves as regulatory… more
- Boehringer Ingelheim (Ridgefield, CT)
- …pharmaceutical industry with experience in Regulatory Affairs. + Specific experience in regulatory advertising and promotion is preferred. + Work history ... have excellent communication skills both verbal and written. + All roles in US regulatory advertising and promotion require complete fluency in the English… more
- Merck (North Wales, PA)
- …include, but are not limited to: + Food, Drug, and Cosmetics Act compliance + Advertising and promotion + Product labeling + Clinical research activities + ... **Job Description** **Position Description:** **Legal Director (FDA promotion / Labeling Drugs & Vaccines)** The position provides legal support to the Human… more
- Bausch Health (Philadelphia, PA)
- …for forwarding to the FDA Office of Prescription Drug Promotion (OPDP) or Advertising and Promotion Labeling Branch (APLB) as appropriate. + Continually ... monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency... labeling processes + Previous course training in advertising and promotion and attendance at training… more
- Bausch Health (Bridgewater, NJ)
- …in the current regulatory environment at FDA's Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and ... new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion ...impact of proposed labeling changes on product promotion . + Develops communication packages for regulatory … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …submissions, regulatory compliance, regulatory advice and counseling, advertising and promotion reviews, and marketing application registration updates ... develops, and implements strategic and tactical support for commercial, post approval regulatory activities for successful and compliant promotion and scientific… more
- Bausch + Lomb (Bridgewater, NJ)
- …assess and determine the impact of proposed labeling changes on product promotion . + Communicate with regulatory authorities on the companies behalf. + ... conform to all applicable laws and regulations. **Responsibilities:** + Provides regulatory review and approval of advertising and promotional materials,… more
- Teleflex (Maple Grove, MN)
- …employees (peers and management) on market authorization trends, promotion and advertising , and other relevant regulatory topics with business impact. * ... Sr. Regulatory Affairs Specialist **Date:** Apr 13, 2024 **Location:**...documentation from guidance/strategies/authoring/obtaining approvals. * Review and approve all labeling (product, advertising , instructions for use, and… more
- Bausch + Lomb (Rochester, NY)
- … affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising , Labeling , Change Control, Commercialization, ... and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices. + Ability to influence and partner… more
- Fresenius Medical Center (Waltham, MA)
- …reviews all types of documents for regulatory submission, including product labeling and promotional and advertising material. + Conducts regulatory ... The ideal candidate should have US Advertising and Promotion experience. This position...fully remote. **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory … more
- Abbott (Alameda, CA)
- …Principles and requirements of promotion , advertising and labeling ; Domestic and international regulatory guidelines, policies and regulations; Ethical ... our new sensing technology. **The Opportunity** We are presently hiring for a ** Regulatory Affairs Specialist,** as part of the Regulatory Affairs Asia Pacific… more
- Abbott (Westford, MA)
- …Artificial Intelligence (AI) + Job specific responsibilities may include Medical writing. Advertising and promotion . Labeling . Controlled substances (eg DEA) ... in Westford MA, currently has an opportunity for a ** Regulatory Affairs Project Manager** . As an individual contributor,.... As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of… more
