Senior Program Director, Commercial Regulatory Affairs

Job Description

Job Summary:

• The CORA Department reports into the Head of U.S. Regulatory Affairs and is focused on the U.S. Market.
• Program Directors in CORA chair Program Review Committees (PRCs) for their assigned responsibilities, e.g., products within a designated therapeutic area(s) or cross-portfolio activities, such as managed care, interactive marketing, etc.
• Program Directors lead and manage the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion regulatory review and approval for Client pharmaceutical products.
• Senior Program Directors may be assigned responsibilities for leading complex product launches, combination product PRCs, departmental programs, projects or other deliverables with limited direction.
• Like Program Directors, Senior Program Directors will coordinate assigned deliverables and guide these when working with other team members, including within and outside of CORA.

Duties and Responsibilities:

PRC Leadership:

• Lead/chair PRCs and effectively collaborate with cross-functional internal groups and external advertising agencies; acting as the decision-maker for PRCs in the assigned therapeutic or business area.
• Typically assigned PRC responsibilities for complex products or business areas.
• Serve as Functional Leader for CORA with internal partner groups, developing plans to strengthen PRC and other key regulatory review processes.
• Monitor PRCs and provide management oversight for various scenarios that require such oversight, e.g., Food and Drug Administration (FDA) communications, audits, POC presentations, compliance violations, etc.
• Represent client in official FDA communications and sign-off on 2253s.
• Act as a primary Client liaison to the FDA on relevant CORA activities.
• Stay abreast of developments in therapeutic and disease areas, including the competitive landscape and other relevant commercial and development trends and dynamics to ensure a fully current view of implications for client products.
• Obtain and apply in-depth knowledge of Client and regulatory guidelines, policies, procedures and best practices.
• Maintain current awareness of evolving FDA opinions; including advisory letters, enforcement letters and policy issues.
• Communicate significant changes or other relevant matters to internal partners and stakeholders.
• Collaborate with commercial leadership to influence marketing strategies, implementation and promotion objectives.
• Facilitate the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from the FDA and Client policies.
• Provide regulatory input on concepts and draft materials.
• Develop and implement effective strategies for FDA marketing, advertising and communications submissions.
• Develop and deliver initial correspondence with the FDA and manage interpretation of FDA comments. Oversee and guide follow-on correspondence, such as resubmissions.
• Actively represent commercial regulatory for Core Data Sheet (CDS) and U.S. product label development.
• Support development of the cross-functional regulatory strategy for each product or portfolio assignment by providing commercial regulatory affairs expertise, insights, perspective and recommendations.
• Provide oversight and decision-making leadership to junior CORA staff as well as day-to-day guidance to other CORA team members supporting the same PRCs or other assignments.
• Keep internal partners and stakeholders abreast on primary PRC/CORA activities and status.
• Consult direct manager on all matters related to FDA communications, audits, POC presentations and compliance violations.

Other:

• As appropriate, participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products.
• As appropriate, represent CORA cross-functionally and support effective and efficient cross-functional coordination, appropriate resources, and timely, thorough and compliant execution.
• Coach and mentor new or less experienced CORA staff members. Be viewed and respected as a leader within CORA.
• Lead other special projects, as and when assigned, or otherwise requested.
• Successful candidates will demonstrate the following competencies critical to this position:

Strategic Agility:

• Articulates wise, long-term objectives and strategies.
• Provides focus and direction to successfully navigate complexity and uncertainty.
• Links his/her responsibilities with the mission of the whole organization.
• Regularly updates plans to reflect changing circumstances.
• Focuses on activities that provide the most value.

Decision Making:

• Understands the broad context for decisions and reflects that context in how decisions are made.
• Makes good decisions even in the face of ambiguous circumstances or contradictory requirements.
• Able to manage divergent perspectives and to deliver difficult or unwelcome information in a constructive and productive manner.
• Expresses regulatory position and rationale, fluently and eloquently.
• Encourages direct and open discussions about important issues – and is able to eliminate churn and drive toward clarity.

Inspiring and Influencing:

• Infuses the organization with a sense of purpose.
• Is able to pull people together to achieve a common goal.
• Addresses and resolves conflict by creating an atmosphere of openness and trust.
• Establishes strong collaborative relationships.
• Inspires others to do their best work by offering support and encouragement.
• Rallies support throughout the organization to get things done.
• Fosters an exchange of ideas and support amongst colleagues.
• Is good at promoting an idea or vision: persuading.
• Works effectively with other people over whom he or she has no direct authority.
• Understands what motivates other people to perform at their best.

Technical and Business Expertise:

• Demonstrates ongoing commitment to reduce complexity across the organization.
• Builds alliances with internal and external customers that strengthen our reputation and create new value.
• Has a firm grasp of internal and external conditions affecting the organization.
• Applies emerging knowledge and trends in one’s area of expertise to improve results.
• Builds strong relationships with key customers.
• Contributes expertise to help colleagues within and beyond his or her area.

Managing Change:

• Effectively manages change; explaining the context, answering questions, and patiently listening to concerns.
• Effectively involves key people in the design and implementation of change.
• Introduces needed change even in the face of opposition.

Innovation:

• Consistently generates new ideas.
• Leverages the unique talents and viewpoints of others.
• Seeks new opportunities and tries new approaches.

Education:

• 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).

Experience:

• 7 or more 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 or more 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.
• Must demonstrate 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.).

Additional Skills:

• Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, Client Values, Competencies and Leadership Commitments (where applicable).
• Regarded as a subject matter expert in regulatory.
• Consistently provides expertise and support in guiding cross-functional projects/teams to mitigate risks and capitalize on opportunities.
• Strong influencing and negotiation skills: proven effectiveness leading diverse teams and influencing stakeholders of varying organizational levels without direct authority.
• Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications.
• Prepares well-researched and properly-toned emails in response to policy questions.
• Thinks “outside the box” for solutions. Applies creative problem-solving and appropriate business solutions to effectively address compliance risk.
• Excellent project management skills; can prioritize multiple tasks and goals to ensure timely, on-Client and within budget accomplishment of such.
• Demonstrates ability to identify appropriate resources. Exercises good judgment in terms of when to leverage internal resources.
• Strong business acumen: understands how the business “works” and demonstrates consistently effective “navigation” across the organization.
• Strong process orientation: has proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness.
• Ability to travel (10%).