Associate Director, Regulatory Affairs (AdPromo)

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.

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 for assigned products to assure all advertising and promotional materials are following regulatory requirements and company policies.
• Provides guidance and strategic support on claims in development for products.
• Regularly monitors the regulatory compliance trends in industry, helps interpret new regulations, guidance documents and enforcement letters.
• Monitors competitor advertising to keep abreast of market promotional and advertising strategies.
• Develops communication packages for regulatory advice, response to FDA action letters, and helps lead the company in discussions with OPDP.
• 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 6 years of relevant pharmaceutical industry experience with 4 years of relevant prescription product advertising and promotion review experience. Strong capability to work in a team environment
• Excellent communication skills, both oral and written
• Strong interpersonal skills with the ability to influence others, without authority, in a positive and effective manner
• Strong knowledge of regulations related to prescription drug promotion and working knowledge of Rx NDA and labeling development and approval process.
• Demonstrated negotiation and problem-solving skills.
• Proven attention to detail while at the same time seeing the big strategic picture.
• Proven ability to thrive in a fast-paced, dynamic environment and effectively manage multiple priorities
  
  

As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by many factors including skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $160k - $200k.

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.

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We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, national origin, disability, military and/or veteran status, or any other Federal or State legally protected classes.

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 humanresources@bauschhealth.com 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.

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To learn more please read Job Offer Fraud Statement (https://www.bauschhealth.com/siteassets/pdf/bausch-health-fraud-statement.pdf) .

Bausch Health is an EEO/AA employer M/F/D/V.