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Position Summary:

The Associate Director, Intercontinental Regulatory Strategic Operations will be responsible for advising and supporting the International Strategy Lead(s) and the local GRS across multiple therapeutic area(TA) on operational excellence and strategy implementation aspects .

Position Responsibilities

• Provides strategic leadership for regulatory strategy across all therapeutic areas and geographies across GRSs Intercontinental.

• Provide operational support to geographies and strategy group to drive meaningful business outcomes.

• Support the annual refresh of GRS Intercon Strategy operations vision and priorities and support the development of strategic initiatives to ensure the Strategy group is clear and proactive on yearly objectives.

• Drive execution of GRS Intercontinental strategy by acting as project manager to track and monitor completion of top strategic initiatives.

• Support select top GRS Intercon strategic initiatives by collaborating with cross-functional stakeholders, determining the necessary solution, and understanding all component while considering the bigger picture (e.g., problem to be solved, various stakeholders involved, processes to be implemented, system capability requirements, etc.).

• Develop and support quality metrics to regularly provide insights and learnings to leadership in order to inform and enable value-added decision-making.

• Identify and oversee strategic initiatives for process and system improvements that impact GRS Intercon, the sustainability and gap-to-goal refresh process (working closely with cross functional stakeholders).

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Qualifications

• Scientific background with a minimum of a bachelor’s degree is required. Advanced scientific degree preferred (Masters, PhD, PharmD, BSN, MD, etc.)

• Minimum of 7 years in the pharmaceutical industry with at least 5+ of relevant Regulatory Affairs. 

Key Competency Requirements

• Strong knowledge of pharmaceutical industry issues, trends, and their business impact preferred.

• Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.

• Highly organized and motivated individual possessing strong leadership and analytical skills, with proven ability to pay attention to detail while maintaining focus on the bigger picture.

• Strong experience in working with & influencing senior management; ability to influence analysis undertaken by other functions; works well with and exerts influence on multi-disciplinary teams; facilitates candid dialogue and cross-functional collaboration.

• Proven ability to manage multiple projects efficiently with a high degree of independence, while being flexible and adapting quickly to the changing needs of the organization; consistently delivers on commitments in a timely manner.