Associate Director, Regulatory Affairs (Advertising ...

Join a team We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence. We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it-where your skills and values drive our collective progress and impact. The Associate Director, Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities : Provides regulatory review of advertising and promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements. Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies. Monitors FDA activity including enforcement actions, guidance documents, etc. to analyze and assess impact on company products and communicates risk to PRC(s). Trains regulatory staff as required. Monitors competitor advertising to keep abreast of market promotional and advertising strategies and assesses potentially violative competitive materials for forwarding to the FDA Office of Prescription Drug Promotion (OPDP) or Advertising and Promotion Labeling Branch (APLB) as appropriate. Continually assesses advertising and promotion - related processes and procedures to enhance efficiencies and compliance. Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. Assures that promotional PIs and Important Safety Information are updated as appropriate. Other job responsibilities as needed. Qualifications: Bachelor's degree required. Science or health related discipline preferred. (Advanced degree [PhD, MD, MS, PharmD] preferred) Minimum of 8 years of relevant pharmaceutical industry experience with 4+ years of relevant prescription product advertising and promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. Detail-oriented with the ability to proofread and check documents for accuracy as well as consistency Strong capability to work in a team environment Strong business acumen and the ability to see business drivers outside of regulatory affairs Working knowledge of the Rx product NDA and labeling processes Previous course training in advertising and promotion and attendance at training conferences a plus Excellent communication skills, both oral and written Strong interpersonal skills with the ability to influence others, without authority, in a positive and effective manner Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts. #LI-hybrid This position may be available in the following location(s): [[location_obj]] We thank you in advance for your interest in growing and developing with our company. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role. Any exception will have to be authorized by your HR Business Partner. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration. If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number. Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms. To learn more please read Job Offer Fraud Statement (. Bausch Health is an EEO/AA employer M/F/D/V.

Created: 2024-11-02