Associate Director Of Regulatory Affairs

Job Detail Experience Level Associate Director Degree Type Bachelor of Arts (BA)
Employment Full Time Working Type Hybrid Job Reference Salary Type Annually Industry Pharmaceuticals Selling Points Lead impactful regulatory projects ensuring compliance with FDA standards. Collaborate across departments to streamline processes and drive innovation. Hybrid work arrangement offering flexibility and growth opportunities.

Job Description Associate Director of Regulatory Affairs Overview The Associate Director of Regulatory Affairs will oversee advertising and promotional compliance for pharmaceutical products.

Provide strategic regulatory advice for product communication and disease area initiatives.

Collaborate with cross-functional teams including Marketing, Legal, and Medical Affairs to ensure compliance.

Maintain up-to-date knowledge of FDA regulations and industry standards.

Lead efforts to streamline review processes and minimize complexity.

Serve as the primary contact for FDA’s Office of Prescription Drug Promotion (OPDP).Develop and deliver training on FDA advertising and promotion regulations.

Contribute to health authority negotiations and ensure accurate submission of promotional materials.

Hybrid work arrangement offering flexibility and professional growth opportunities.

Associate Director of Regulatory Affairs

Key Responsibilities & Duties Review and provide oversight for product and disease state education materials.

Ensure alignment with FDA regulations and approved labeling standards.

Participate in multidisciplinary teams such as Copy Clearance and Global Regulatory Teams.

Establish and revise procedures to maintain compliance with advertising and promotion requirements.

Build and maintain strong relationships with internal stakeholders.

Provide training and guidance on FDA regulations to employees and agents.

Shape strategies based on emerging trends and regulatory updates.

Lead efforts to simplify and enhance review processes for promotional materials.

Submit promotional materials to FDA under Form FDA-2253 accurately and promptly.

Associate Director of Regulatory Affairs

Job Requirements Bachelor’s degree in a health or science-related field; advanced degree preferred.

Minimum of 7 years of experience in Regulatory Advertising and Promotion Review.

High-level knowledge of FDA laws, regulations, and industry standards.

Strong understanding of clinical trial design and data interpretation.

Excellent interpersonal and communication skills, both written and verbal.

Ability to negotiate business decisions and drive compliance solutions.

Travel up to 20% may be required for the role.

Proven ability to communicate complex issues clearly and concisely.

Experience in leading cross-functional teams and regulatory projects.