Associate Director, Global Regulatory Labeling, Ad Promo

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the creation, assessment, and upkeep of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use, primary and secondary carton labeling, and promotional materials.

• Offer regulatory advice on product labeling during the development, registration, launch, and post-approval phases of the product lifecycle.

• Collaborate with teams across clinical, CMC, medical, safety, device engineering, technical operations, and commercial sectors.

• Assist in negotiations regarding labeling with the FDA and manage the implementation of approved labeling revisions.

• Assess proposed safety, efficacy, and scientific claims to ensure alignment with approved labeling.

• Act as a key participant in the Medical, Legal, Regulatory review process and work closely with the MLR process owner.

• Ensure adherence to FD&C Act requirements, FDA advertising and promotion regulations, OPDP guidance and enforcement trends, PhRMA Code requirements, along with company policies and procedures.

• Provide regulatory advice for compliant and effective non-promotional and promotional communications.

• Keep abreast of evolving FDA guidance, enforcement actions, warning letters, and industry best practices.

• Contribute to the development of SOPs, policies, and governance processes.

⛳️ Requirements

• An advanced degree (such as PhD, PharmD, MS, MBA) with a minimum of 5 years of pertinent drug development experience, particularly in product labeling, or a bachelor’s degree with over 10 years of experience.

• Solid understanding of regulatory guidelines and regulations (both US and international), especially in the areas of product labeling and advertising promotion.

• Profound knowledge of the integrated drug development process.

• Capability to devise solutions and alternatives through collaborative teamwork that leads to favorable business results.

• Proficiency in assessing and managing risks within a highly regulated setting.

• Excellent written, verbal, and presentation communication skills.

• A strong desire to advance a career in the pharmaceutical sector, combined with a willingness to learn and an enthusiasm for new opportunities.

• Expected travel of 10–15%.

• Bachelor’s degree with over 10 years of experience or an advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of experience.

• New hires must complete employment eligibility verification through E-Verify.

🏝️ Benefits

• Comprehensive health coverage.

• Flexible time off.

• Paid holidays.

• Year-end shutdown.

• Monthly wellness stipend.

• Generous 401(k) matching contributions.

• Tuition reimbursement.

• Commuter benefits.

• Disability insurance.

• Life insurance.

• Opportunities for annual bonuses.

• Equity grants.