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 Vice President Global Regulatory Affairs – Brand, Generics, & Medical Devices provides innovative and inspiring management and leadership to the Regulatory Affairs organization, in the development and execution of regulatory strategies and processes to gain product approvals and maintain regulatory compliance in the market.

　　This incorporates accountability for regulatory strategy development and execution, interactions with the FDA Regulatory Authorities for prescription and consumer products. Performs due diligence reviews on new product opportunities.

　　Responsibilities:

　　· Provide the highest quality leadership, management and development of the Regulatory Affairs team, leaning on personal in-depth expertise across all aspects of pharmaceutical regulatory affairs, including NDAs, ANDAs, BLAs

　　· Overarching responsibility for development and execution of innovative and robust regulatory strategies for prescription drug products, from early-stage development through to life-cycle management.

　　· Responsible for ensuring regulatory goals, timelines and milestones are developed and adhered to, in alignment with the corporate strategic priorities.

　　· In support of strategic partnering and licensing, ensure the provision of guidance and critical evaluation of potential product opportunities to the business development team

　　· Apply in-depth knowledge of the research and development, preclinical and clinical processes, and related regulations in pharmaceutical development, with a detailed understanding of the commercial strategy.

　　· Serve as the primary regulatory contact for FDA for all regulatory affairs matters, including full support for all relevant inspections, plus diligently communicating and mitigating drug shortages.

　　· Drive and maintain the highest level of regulatory compliance.

　　· Proactively identify key relevant regulatory issues and trends, clearly communicate the impact to senior management and develop and deploy necessary action plans.

　　· Foster a culture of talent development & learning culture by proactively coaching and assisting the team, providing relevant coaching and training sessions, developing and sharing interpretations of FDA guidance and other pertinent regulatory concerns.

　　· Foster an environment of continuous improvement, relentlessly seeking process excellence to gain maximum efficiencies and effectiveness.

　　· Foster an environment of Diversity and Inclusion

　　· Actively encourage collaborative coordination with cross-functional business partners.

　　· Leads and contributes to initiatives within the organization, with internal groups engaged in developing good regulatory practice and policy, and holistically within the regulatory profession.

　　· Diligently focus on departmental planning including structure, headcount, budgeting

　　Qualifications:

　　· Bachelor’s degree required; Advanced degree preferred (PhD, MD, MS, PharmD)

　　· Minimum 15 years relevant regulatory experience in the pharmaceutical industry required

　　· Therapeutic knowledge in GI , Dermatology, or Medical Device preferred.

　　· In depth experience of 505b2 strongly preferred.

　　· Pharmaceutical prescription drug experience required

　　This position may be available in the following location(s): [[location_obj]]

　　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 [email protected] 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 Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/379301a79c224eae9f25e08c7426cedde0ec4807) .

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