Associate Director, Commercial Regulatory Affairs

Meet Life Sciences; United States; Remote; USD 190,000 - 230,000; Full time

Job summary

A leading company in the biopharma sector is seeking an Associate Director for Commercial Regulatory Affairs. This role involves ensuring compliance with FDA regulations, leading promotional material reviews, and collaborating with various departments. Ideal candidates will have significant experience in regulatory affairs and strong leadership skills. The position can be remote, primarily for East Coast candidates, with travel to Boston as needed.

Qualifications

• Minimum 6 years in the pharmaceutical industry, with 4+ years in commercial regulatory affairs.
• Expertise in FDA regulations and promotional review processes.

Responsibilities

• Provide regulatory advice on FDA advertising and promotion issues.
• Lead the Promotional Review Committee process to ensure compliance.
• Collaborate with cross-functional teams to integrate regulatory guidance.

Skills

Communication

Negotiation

Leadership

Job description

Associate Director, Commercial Regulatory Affairs

Associate Director, Commercial Regulatory Affairs

This range is provided by Meet Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$190,000.00/yr - $230,000.00/yr

Direct message the job poster from Meet Life Sciences

Lead Recruiter at Meet | Life Science Recruitment

We're partnered with a global biopharma that is seeking an Associate Director, Commercial Regulatory Affairs to lead the review and approval of promotional and medical communications for assigned brands. The role involves interacting with regulatory bodies like the FDA, ensuring compliance with regulations, and guiding internal teams through promotional material development. This position requires collaboration with multiple departments, including legal and business ethics, to ensure products' promotional communications meet all required standards.

*This position can be based remotely across the East Coast and will have travel as needed to Boston

Key Responsibilities:

• Provide regulatory advice on FDA advertising and promotion issues for assigned products.
• Lead and manage the Promotional Review Committee (PRC) process and ensure materials meet regulatory standards.
• Develop and implement standard operating procedures (SOPs) to streamline processes.
• Liaise with regulatory agencies for product submissions and compliance.
• Collaborate with cross-functional teams to integrate regulatory guidance into business strategies.
• Manage tasks to support the compliant execution of marketing strategies and materials.

Qualifications:

• Minimum 6 years of experience in the pharmaceutical industry, with 4+ years in commercial regulatory affairs.
• Expertise in FDA regulations, promotional and medical review processes, and product labeling.
• Strong communication, negotiation, and leadership skills.

Core Competencies:

• Ability to interpret clinical trial data and understand promotional regulations.
• Excellent attention to detail and communication skills.
• Ability to influence cross-functional teams and lead multiple projects.

To learn more and have a confidential discussion, please reach out to Amit at [e-mail].

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Advertising and Marketing

• Industries

  Pharmaceutical Manufacturing

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