Director, Regulatory Affairs (Global Labeling)

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 Global Labeling Director provides regulatory expertise and guidance for labeling strategy, to deliver high quality submission labeling and artwork for complex drug products, specific therapeutic/disease areas, and cross functional teams. Facilitate strategic development of labeling and labeling components, by leading a diverse cross-functional labeling sub team through discussion and decisions. Has a key role by sharing knowledge, providing labeling guidance, leading cross functional labeling teams and driving label development and execution. May also provide Labeling Operations oversight and direction for the graphics process and systems.

Key responsibilities:

• Lead preparation, review, and update of content for the development and maintenance of Target Product Profile (TPP), Company Core Data Sheet (CCDS), local labeling (USPI, SmPC, Canadian monographs) and labeling components.
• Evaluate and communicate risks associated with CCDS content updates and implementation strategies.
• Support global HA interaction strategy to discuss key labeling elements
• Demonstrate high-level understanding of labeling content requirements, regulations, and guidance in support of labeling strategies worldwide.
• Analyze and interpret new regulations and guidance, as well as monitor and determine impact on product labeling. Provides strategic advice on implementing new regulations.
• Assess competitor labeling - understand precedents & opportunities for Health Authority (HA) discussions
• Provide operational guidance and oversight to ensure all labeling documents are accurate, consistent, and compliant with all current regional regulatory regulation, guidance, templates, and requirements.
• Manage and maintain labeling documents in document management systems; Manage label review and approval.
• Partner with Regulatory Managers to ensure that all labeling is submission ready and available for publishing.
• During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies.
• Lead, represent or contribute on product-specific Regulatory and Cross-Functional teams, as appropriate.
• May drive labeling operations strategy to deliver high-quality submission labeling and artwork (prescribing information, patient labeling, and package labeling), that meets timelines and complies relevant Health Authority guidance and regulation.
• Drive labeling operations strategy for package labeling (artwork) development, update, and maintenance through collaboration with Commercial, Supply Chain, GRA Lead and  if need for Human Factors

Qualifications:

• Bachelors degree required; advanced scientific degree (MSc, PhD or PharmD) preferred.
• 8+ years of relevant experience in pharmaceutical labeling/regulatory experience.
• Thorough understanding of scientific principals and regulatory systems, relevant to drug development
• Experience writing CCDS and USPI documents for new products.
• Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and industry practice
• Exceptional understanding of medical concepts and terminology
• Strong written and oral communication skills, including presentation skills
• Solid ability to recognize and escalate issues

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

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.  

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.