Senior Director, Regulatory Affairs (Ad Promo)

Responsibilities

• Manages the Regulatory Promotional reviewers for products who represent Regulatory Affairs on the promotional review committee for preapproval and marketed products.
• This position may require reviewing promotional materials if the company requires it and escalates issues as necessary.
• Ensures compliance with regulatory requirements while supporting the company's strategic promotional objectives.
• Provides guidance on proposed claims for products in development and develops ISI and brief summaries.
• Maintains awareness of regulatory compliance trends in the industry, interprets new regulations, guidance documents, and enforcement letters.
• Updates Regulatory Ad Promo staff, review committees, and other company staff regarding changes in the regulatory environment.
• Develops or revises procedures needed to address regulatory concerns.
• Reviews packages for regulatory advice, resolves FDA and Canadian action letters, and leads discussions with regulatory bodies.
• Coordinates company-wide regulatory training on promotion-related issues.
• Represents regulatory affairs in cross-functional promotional review teams as needed.
• Participates in the development of processes and procedures related to advertising and promotion.
• Interacts with Legal, Compliance, and Medical Affairs regularly.
• Works with Quality to support internal audits and Corrective Action Preventative Action (CAPA) initiatives, as needed.

Qualifications

• Bachelor’s degree in science or health-related discipline required (Advanced degrees such as PhD, MD, MS, PharmD preferred).
• Minimum 10 years of regulatory affairs, product advertising, and promotion experience required.
• Prior experience in gastrointestinal (GI) products is preferred.
• Broad knowledge of the pharmaceutical industry.
• Demonstrated ability to contribute to a continuous learning and process-improvement environment.
• Detail-oriented with the ability to assess documents for accuracy and consistency.
• Strong interpersonal skills with the ability to influence others positively and effectively.
• Ability to work collaboratively in a team environment.
• Working knowledge of pharmaceutical and device development and approval processes.
• Excellent communication skills, both oral and written.

Pay

The range of starting base pay for this role is $215,000 - $296,000. Actual starting pay will be determined based on a variety of factors including relevant skills, experience, qualifications, education, and location.

Benefits

• Comprehensive Medical (including Prescription Drug), Dental, Vision coverage
• Flexible Spending Accounts
• 401(k) with company matching contributions
• Discretionary time off
• Paid sick time
• Stock purchase plan
• Tuition reimbursement
• Parental leave
• Short-term and long-term disability insurance
• Life insurance
• Accidental death & dismemberment insurance
• Paid holidays
• Employee referral bonuses
• Employee discounts

About the Role

Join our global diversified pharmaceutical company, dedicated to enhancing lives through innovative healthcare solutions. Our mission is to drive meaningful change and impact through our commitment to excellence and collaboration.

Skills

• Regulatory Affairs
• Product Advertising and Promotion
• People Management
• Continuous Learning and Process Improvement
• Document Accuracy and Consistency
• Interpersonal Influence
• Team Collaboration
• Pharmaceutical and Device Development
• Communication Skills

Benefits

• Medical (including Prescription Drug)
• Dental
• Vision
• Flexible Spending Accounts
• 401(k) with Matching Contributions
• Discretionary Time Off
• Paid Sick Time
• Stock Purchase Plan
• Tuition Reimbursement
• Parental Leave
• Short-Term and Long-Term Disability Insurance
• Life Insurance
• Accidental Death & Dismemberment Insurance
• Paid Holidays
• Employee Referral Bonuses
• Employee Discounts