VP/TA Head, General Medicine – Global Regulatory Affairs

Job Description

The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research & Development Division by:

• Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.

• Contributing to the continuous improvement of the operating model for regulatory activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.

• Providing quality advice to stakeholders creating optimal development, commercialization, and drug/delivery device supply strategies 

• Building our leadership and functional capability to keep pace with the changing science and regulatory environment.

• Establishing and effective implementation and oversight model to maintain best in industry regulatory compliance.

The Vice President Regulatory Affairs, General Medicine is accountable for:

• Directing and Supervising the General Medicine Therapeutic Area (Regulatory)

• Directing and supervising Worldwide Product Labeling

• Directing and supervising the US Office of Promotion and Advertising Review

• Directing and supervising the US Subsidiary regulatory operations

• Directing and supervising the Drug Device/Combination Products Center of Excellence

• Providing strategic and tactical direction and execution of cross product and GRACS cross functional projects and teams as assigned.

Key Accountabilities:

• Directs activities of the General Medicine global regulatory therapeutic area and team leading to global innovative and accelerated regulatory strategy and marketing authorizations for Cardiovascular, Diabetes, Respiratory, Immunology, Neuroscience and Women’s Health programs. Prioritizes and oversees execution of high quality and timely health authority engagement in attaining desired results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings overseeing the progress of those development programs.

• Inspires a high level of performance in a dynamic environment, leaning into areas of talent management and succession planning, operational efficiency and compliance, and external collaboration and influence through industry affiliations and relationships with health authorities. Leads, develops, and coaches a team of senior level employees to effectively manage programs and enable rapid and effective decision making through empowerment of individuals. Embodies leadership behaviors to interact and increase effectiveness by enabling clear, concise communication directly to senior management at our company.

• Partners with members of GRACS Leadership Team to provide guidance on the application of regulatory activities with cross- product or cross-functional impact, including drug device/combination products and software as medical device platforms.  Reviews and resolves issues that span diverse areas and manages situations that are viewed as precedent setting.  Guides internal teams to implement rigorous, innovative, and science-based approaches to regulatory interactions and requirements.  Uses enhanced business acumen, strategic understanding of the regulatory environment globally and thinks beyond functional and divisional lines to drive decisions and strategies that are innovative, impactful and in our company's best interest.

• Partners with members of GRACS Leadership Team to help our company build solid and trustworthy relationships with FDA and global health authorities. Pro-actively influences and manages relations with FDA and global health authorities to build consensus and ensure our company's regulatory strategies are implemented.

• Partners with members of GRACS Leadership Team to strengthen our collaboration with our company's Chief Patient Office, Global Human Health (Commercial), Center for Observational and Real-World Evidence (CORE) and our Manufacturing Division internally to create a single voice of commitment to regulatory strategies that accelerate and maintain access of product through market authorization, execute of post marketing commitments and meet compliance obligations.

Education:

• M.D. or PhD with >20 years relevant experience preferably with >15 years in Regulatory or M.S. or B.S. with >25 years relevant experience a majority of which was in Regulatory.

Required Experience and Skills:

• Global Regulatory experience required across various modality types.

• M.D. or PhD with >20 year