Director, US Regulatory Affairs - Advertising and Promotion (Hybrid)

Role Summary

Director, US Regulatory Affairs - Advertising and Promotion (Hybrid). Location: Cambridge, MA; Morristown, NJ. Lead regulatory strategy for advertising and promotion, ensuring materials comply with US regulations and company policies. This is an expert role with potential for mentoring and team leadership opportunities, but no direct reports.

Responsibilities

• Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology.
• Analyze issues and opportunities by comparing data from multiple sources to draw conclusions and determine a course of action.
• Participate in strategic decision-making within the regulatory function and day-to-day operations.
• Provide direction and oversight for day-to-day activities for assigned products and departmental activities.
• Offer senior regulatory guidance during issues management, oversee Rapid Response Teams, and serve as the therapeutic product expert.
• Monitor the regulatory environment, interpret new regulations and enforcement trends, and assess impact on the business.
• Develop and implement regulatory strategies for marketed products and mentor others in strategy execution.
• Establish internal relationships with therapeutic product leaders to foster communication and teamwork.
• Ensure alignment and consistency in policy application across therapeutic products.
• Assist in maintaining product support relationships with FDA.
• Contribute to global labeling strategy discussions for marketed drugs.
• Demonstrate significant autonomy in duties and responsibilities.

Qualifications

• Earned Bachelor‚Äôs degree (required) from an accredited four-year college or university in a Life Sciences or related discipline.
• 8+ years of experience in pharmaceutical or medical device Regulatory Affairs, with 5+ years in advertising & promotion functions.
• Leadership, mentoring and/or training experience within regulatory or ad/promo is highly preferred.
• Extensive knowledge of complex medical and scientific subject matter, including statistical data.
• Ability to build networks and lead cross-functional groups to decisions without relying on authority.
• Ability to generate innovative solutions and adapt approaches to problems.
• Strong interpersonal skills and adaptability to gain acceptance of ideas or plans.
• Ability to set priorities, manage timelines, and multitask effectively.
• Honest and forthright communication of information and data.

Skills

• Regulatory strategy development for advertising and promotion
• Cross-functional collaboration (medical, legal, regulatory)
• Regulatory affairs monitoring and interpretation
• Issue management and rapid response coordination
• Labeling strategy input and global regulatory alignment