Director, Regulatory Affairs - AdPromo

Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry.  We are delivering on our commitments as we build an innovative company dedicated to advancing global health.  Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 7,000 employees are united around our mission of improving people’s lives with our health care products.

The Director of Advertising and Promotion, Prescription Drug Products manages and/or participates in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces.  The Director is responsible for ensuring the pieces are in compliance with all applicable laws, regulations, and regulatory agency guidance.

KEY ACTIVITIES/RESPONSIBILITIES: 

• Manages or represents Regulatory Affairs on the promotional review committees for prescription products to review promotional materials to ensure compliance with regulatory requirements while meeting the Company's strategic promotional objectives.
• Implements regulatory strategies and solutions to assure that all advertising and promotional materials are in compliance with regulatory requirements and Company policies.
• Provides guidance and strategic support on proposed claims for products in development and helps develop Important Safety Information (ISI) and Brief Summary documents as appropriate.
• Continually develops, assesses and revises advertising and promotion-related processes and SOPs as needed, to enhance efficiencies and compliance.
• Regularly monitors the regulatory compliance trends in industry, interprets new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA’s Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory considerations that may impact business. 
• Works closely with the Regulatory Affairs prescription drug labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion.
• Develops communication packages for regulatory advice, response to FDA action letters, and leads the company in discussions with OPDP and APLB.
• Coordinates company-wide ongoing training on regulatory issues pertaining to product promotion. Other job responsibilities as needed.

QUALIFICATIONS/TRAINING: 

• Bachelor’s degree in science or health related discipline (Advanced degree [PhD, MD, MS, PharmD] highly preferred)
• Knowledge of regulations related to prescription drug promotion
• Previous course and/or conference training in advertising and promotion 
• Working knowledge of Rx NDA and labeling development and approval process
• Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency
• Strong interpersonal skills with the ability to influence, without authority, others in a positive and effective manner

EXPERIENCE:

• Minimum of 10 years of relevant pharmaceutical industry experience with 5+ years of relevant Regulatory Affairs prescription product advertising and promotion review experience. Supervisory experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.
• Demonstrated ability to contribute to a continuous learning and process improvement environment.

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): US - Remote

Bausch Health Companies Inc. is 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 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 Bausch Health's Job Offer Fraud Statement.