Regulatory Manager (Pharma)

Job Overview

Key Responsibilities

Qualifications And Skills

Reports To

Benefits

• Lead the regulatory strategy and execution of the highest-complexity, highest-priority, and most visible regulatory submissions, ensuring adherence to FDA regulations and internal guidelines.
• Act as the primary point of contact for MLR reviews, providing regulatory expertise and guidance to internal teams and clients.
• Develop and maintain regulatory policies, procedures, and training materials for assigned account(s) to ensure compliance across all teams.
• Conduct thorough reviews of promotional materials to ensure accuracy and compliance with relevant regulations.
• Track industry trends and changes in regulatory requirements, working with the Associate Director and Director of Regulatory to improve internal processes and training as necessary.
• Mentor and develop direct reports to enhance their understanding of compliance challenges and best practices, and oversee their workload distribution, performance management, and professional development.
• Collaborate with clients to address regulatory questions and concerns, fostering positive relationships and ensuring satisfaction.
• Participate in leadership meetings to report on regulatory compliance status and present improvements.
• Work to increase the efficiency of the MLR review process through streamlined workflows and enhanced communication.

Bachelor's degree (Life sciences, healthcare, communications, English, or similar) or equivalent experience (recommended)

3+ years experience with regulatory or legal review processes in healthcare or other regulated industry, or 2+ years agency experience in regulatory or editor role, or equivalent experience in a client-side MLR-focused role

2+ years supervisory experience or equivalent education/training

Strong knowledge of FDA regulations and MLR processes

Demonstrated ability to lead teams and manage multiple projects simultaneously in a fast-paced environment

Successful history of guiding change

Excellent written and verbal communication skills, with a keen eye for detail

Proficient in the use of project management and collaboration tools, as well as Adobe Acrobat and Microsoft Office Suite

(Preferred): Previous experience in agency settings or working directly with healthcare clients

(Preferred): Working knowledge of Veeva Vault PromoMats or similar content management and review platform

Salary Range

The estimated salary range for this position is $95,000 - $110,000 USD.

Benefits

• Health benefits
• 401K retirement with a generous company match and immediate vesting
• Flexible time off

This position is eligible to participate in a discretionary bonus program, subject to the rules governing the plan.