Senior Program Director, Commercial Regulatory Affairs

Commercial Regulatory Affairs (CORA)

Commercial Regulatory Affairs (CORA) interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers, and prescribers for global Pharma Division, which includes all therapeutic areas and all phases of product development, from early development to post marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry.

Requirement/Must Have:

• Bachelors Degree (life sciences, law, public policy, marketing, business, education, or related discipline preferred).
• Graduate-level Degree strongly preferred (JD, MBA, MS, PharmD or other PhD, or related discipline).
• 7+ years work experience in regulatory, legal, compliance, policy, auditing, training, communications or related disciplines in the bio/pharma industry.
• Regulatory advertising and promotion experience strongly preferred.
• 4+ years previous experience leading large-scale, cross-functional project teams or other forums in design, development and implementation of policies, programs or projects with significant organizational impact strongly preferred.
• In-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).

Responsibilities:

• Lead Program Review Committees (PRCs) independently.
• Assume responsibility for leading significantly complex product launches, combination product PRCs, departmental programs, projects and other deliverables with limited direction.
• Demonstrate mastery of the review committee process and regulatory technical knowledge.
• Act as the decision-maker for the PRCs in their designated therapeutic or business area assignments.
• Support development of therapeutic-area strategy, conducting and summarizing product-specific analyses.
• Represent the organization in official FDA communications and sign-off on 2253s.
• May serve as a subject matter expert (SME) for CORA with other departments.
• Effectively lead complex department projects (organizational design, long-range budget, capacity planning, organizational effectiveness, employee engagement, CORA strategy, vision, strategic objectives, etc.).
• Keep current in the areas of regulatory, healthcare compliance and ethics.
• Proactively identify and address compliance issues.
• Regularly lead cross-functional interactions, projects and teams.
• Represent CORA on cross-functional review/decision-making committees of significant impact across the organization.

Skills:

• Strong influencing and negotiation skills.
• Strong verbal and written business communication skills.
• Excellent project management skills.
• Strong business acumen.
• Strong process orientation.

Qualification And Education:

• Impeccable ethics.
• Demonstrated ability to provide expertise and support in guiding cross-functional projects/teams to mitigate risks and capitalize on opportunities.
• Ability to travel (?10%).