Executive Director, Regulatory Affairs (AdPromo) jobs in United States
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Bausch Health Companies Inc. · 2 weeks ago

Executive Director, Regulatory Affairs (AdPromo)

Bausch Health Companies Inc. is a global diversified pharmaceutical company dedicated to improving health outcomes. The Executive Director of Advertising & Promotion - Regulatory Affairs manages the review and approval of promotional labeling for drug and device products, ensuring compliance with regulatory requirements while supporting the company's strategic objectives.

BiotechnologyHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Manages the Regulatory Promotional reviewers for products who represent Regulatory Affairs on the promotional review committee for preapproval and marketed products. This position may require reviewing promotional materials if the company requires it and escalations. This person is responsible for compliance with regulatory requirements while meeting Company's strategic promotional objectives
Provide guidance on proposed claims for products in development and development of ISI and brief summaries
Regularly monitor the regulatory compliance trends in industry, interpret new regulations, guidance documents and enforcement letters
Update the Regulatory Ad Promo staff, review committees and appropriate other company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP), Canada Pharmaceutical Advertising Advisory Board (PAAB) and other regulatory considerations that may impact business. Develop or revise procedures needed
Review packages for regulatory advice, resolution of FDA and Canadian action letters and leads the company in discussions with the FDA OPDP and Canada PAAB
Coordinate companywide ongoing regulatory training on regulatory issues pertaining to promotion of Company products
Represents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo
Interacts with Legal, Compliance and Medical Affairs regularly. Also works with Quality related to internal audits and CAPAs, as needed

Qualification

Regulatory AffairsAdvertisingPromotionPharmaceutical Industry KnowledgePeople ManagementPharmaceutical Development ProcessInterpersonal SkillsTeamworkCommunication SkillsDetail-oriented

Required

Bachelors degree in science or health related discipline required
Minimum 15 years of regulatory affairs product advertising and promotion and people management experience required
Broad knowledge of the pharmaceutical industry
Demonstrated ability to contribute to a continuous learning and process improvement environment
Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency
Strong interpersonal skills with the ability to influence others in a positive and effective manner
Ability to work in a team environment
Working knowledge of pharmaceutical and device development and approval process
Excellent communication skills; both oral and written

Preferred

Advanced degree PhD, MD, MS, PharmD preferred
GI experience preferred

Benefits

Comprehensive Medical (includes Prescription Drug)
Dental
Vision
Flexible Spending Accounts
401(k) with matching company contribution
Discretionary time off
Paid sick time
Tuition reimbursement
Parental leave
Short-term and long-term disability
Life insurance
Accidental death & dismemberment insurance
Paid holidays
Employee referral bonuses
Employee discounts

Company

Bausch Health Companies Inc.

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Bausch Health Companies Inc.

H1B Sponsorship

Bausch Health Companies Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (7)
2023 (4)
2022 (13)
2021 (4)
2020 (5)

Funding

Current Stage
Public Company
Total Funding
$7.4B
Key Investors
Kohlberg Kravis Roberts
2025-05-21Post Ipo Debt· $2.52B
2025-03-25Post Ipo Debt· $3.08B
2023-07-07Post Ipo Debt· $600M

Leadership Team

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Thomas J. Appio
Chief Executive Officer
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Graham Jackson
SVP, Chief Quality Officer & Global Head Technical Operations
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Company data provided by crunchbase