Senior Director, Regulatory Affairs

Merck • North Wales, PA

2d • $173,200 - $272,600 • Hybrid

About The Position

The Senior Director manages a team of promotional regulatory professionals in the regulatory review of U.S. promotional materials for assigned products. Leads a team of promotional regulatory reviewers (senior specialists, associate directors, and individual contributor directors) to provide regulatory strategy across multiple therapeutic franchises for pipeline and in-line products that competitively positions our company's products, consistent with applicable FDA regulations and company policies for US advertising and promotion. Ensures strategy is aligned with overall corporate strategy and organizational goals. The senior director will be responsible for providing a regulatory risk assessment and managing escalations with senior leaders. Partners with commercial and other stakeholders to develop a promotional regulatory strategy and product positioning that aligns commercial strategy with regulations. Drives optimal regulatory strategy, planning and delivery for advertising and promotion to support the overall business goals for therapeutic area(s) of focus. Serves as critical leadership point of contact for assigned brands and associated escalations, as needed. Serves as critical partner with HH, Legal and Medical on cross-divisional transformation work inclusive of process redesign and technology enablement. Oversees direct report’s product assignments and ensures collaboration and a cohesive and integrated regulatory strategy from early development through approval and marketing. Provides guidance and coaching to direct reports on their input to product labeling, global regulatory team strategy, adequate support of promotional messaging and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion. Ensures direct reports are compliant with corporate policies and complete all required corporate and compliance training. Demonstrated ability to impact and drive regulatory decisions with senior company leadership and with FDA. Helps shape regulatory policy with OPDP and APLB on emerging topics and innovative technologies. Serves on external promotional regulatory planning committees and contributes to our company's regulatory leadership by presenting at leading external regulatory meetings (DIA, FDLI, RAPS etc.). Identifies the need for development, refinement, and implementation of department and corporate strategic initiatives that drive effective, compliant promotional regulatory review. Analyzes business needs and capacity and contributes to staffing discussions with Executive Director. Serves as a liaison with OPDP and/or APLB Team Leaders or reviewers for business-critical initiatives. Effectively interprets and communicates FDA perspectives to relevant company stakeholders and recommends policy and/or process changes as needed.

Requirements

• Minimum 12 years’ experience in pharmaceutical/biologics regulatory, clinical, medical, legal, and or marketing disciplines, including demonstrated advertising/promotional review work
• Minimum 6 years’ experience reviewing advertising and promotion materials or marketing programs for regulatory/legal compliance
• Expert understanding and application of FDA regulations and company's policies and procedures related to promotion development and implementation and promotion review processes
• Expert understanding of the clinical development process, including labeling development and FDA approval processes
• Demonstrated ability to lead and direct complex activities of a Team and drive work effectively in a cross-functional team environment
• Collaborative – ability to build deep relationships cross-functionally to drive optimal performance
• Demonstrated superior verbal and written communication skills
• Strong interpersonal and negotiation skills with ability to demonstrate strategic and analytic thinking
• Demonstrated ability to negotiate and influence others effectively
• Proven track record of effective collaboration with external stakeholders which may include FDA branches (OPDP, APLB), alliance relationships with peer companies as well as external consortia and trade organizations such as DIA.
• Strong judgment and decision-making skills.
• Business Alignment
• Cross-Functional Project Management
• Decision Making
• Global Regulatory Submissions
• Goal Setting
• Interpersonal Relationships
• Negotiation
• People Leadership
• Policy Reviews
• Policy Revisions
• Regulatory Affairs Management
• Regulatory Communications
• Regulatory Compliance
• Regulatory Documents
• Regulatory Experience
• Regulatory Management
• Regulatory Processes
• Regulatory Reporting
• Regulatory Strategies
• Regulatory Submissions
• Stakeholder Negotiations
• Strategic Planning
• Strategic Thinking

Nice To Haves

• Advanced degree preferred
• Science-related degree such as biology, chemistry, nursing, pharmacy, social sciences, or QA/regulatory affairs strongly preferred
• Preferred Skills: Current Employees apply HERE
• Current Contingent Workers apply HERE

Responsibilities

• Leads a team of promotional regulatory reviewers to provide regulatory strategy across multiple therapeutic franchises for pipeline and in-line products.
• Ensures strategy is aligned with overall corporate strategy and organizational goals.
• Provides a regulatory risk assessment and manages escalations with senior leaders.
• Partners with commercial and other stakeholders to develop a promotional regulatory strategy and product positioning.
• Drives optimal regulatory strategy, planning and delivery for advertising and promotion.
• Serves as critical leadership point of contact for assigned brands and associated escalations.
• Serves as critical partner with HH, Legal and Medical on cross-divisional transformation work.
• Oversees direct report’s product assignments and ensures collaboration and a cohesive and integrated regulatory strategy.
• Provides guidance and coaching to direct reports on their input to product labeling, global regulatory team strategy, and promotional messaging.
• Ensures direct reports are compliant with corporate policies and complete all required corporate and compliance training.
• Impacts and drives regulatory decisions with senior company leadership and with FDA.
• Helps shape regulatory policy with OPDP and APLB on emerging topics and innovative technologies.
• Serves on external promotional regulatory planning committees and contributes to company's regulatory leadership by presenting at external regulatory meetings.
• Identifies the need for development, refinement, and implementation of department and corporate strategic initiatives.
• Analyzes business needs and capacity and contributes to staffing discussions with Executive Director.
• Serves as a liaison with OPDP and/or APLB Team Leaders or reviewers for business-critical initiatives.
• Effectively interprets and communicates FDA perspectives to relevant company stakeholders and recommends policy and/or process changes.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior