i-Pharm Consulting
Director, Regulatory Affairs - Advertising and Promotional Compliance
i-Pharm Consulting, Boston, Massachusetts, us, 02298
Overview
We are seeking an experienced
Director of Regulatory Affairs – Advertising & Promotion
to serve as a Therapeutic Area Lead and regulatory representative for U.S. promotional review. This individual will oversee compliance of promotional materials with FDA regulations, act as the primary point of contact with the FDA’s Office of Prescription Drug Promotion (OPDP), and partner closely with cross‑functional business stakeholders. While this is an individual contributor role, the Director will have oversight and final approval authority for assigned products, managing reviewers within their therapeutic area. This position offers the opportunity to lead a therapeutic area and contribute to shaping strategy, with potential to progress into a more senior leadership position in the future.
Location Location:
Boston, MA (Onsite 3 days/week - you choose what days)
Compensation Base pay range
$225,000.00/yr - $250,000.00/yr
Key Responsibilities
Serve as the
Therapeutic Area Lead
and primary
Regulatory Affairs representative
for assigned products.
Review and approve U.S. promotional materials for compliance with FDA regulations, including OPDP requirements.
Act as the point of contact with the FDA, managing regulatory interactions and submissions as needed.
Partner with Marketing, Legal, Medical Affairs, and other business stakeholders to ensure compliant and effective promotional strategies.
Lead and support the development, maintenance, and implementation of relevant SOPs.
Provide ad/promo compliance guidance and training across the business.
Maintain up-to-date knowledge of industry trends, evolving FDA guidance, and global promotional regulations.
Oversee the work of promotional reviewers within your therapeutic area, ensuring quality and compliance of output.
Qualifications
Bachelor’s degree
required and advanced scientific degree preferred
5+ years of U.S. regulatory advertising & promotion experience
in the pharmaceutical or biotech industry.
Proven expertise in
OPDP interactions , FDA promotional regulations, and global ad/promo standards.
Strong leadership presence with the ability to influence without direct authority.
Exceptional communication skills, with the ability to have constructive yet tough conversations, defend positions, and remain flexible when appropriate.
Collaborative mindset with the ability to build strong, trust-based relationships and find common ground.
Broad therapeutic area experience;
rare disease, oncology, neuroscience, metabolic, or bone
experience preferred but not required.
Experience with both marketed products and pipeline promotional review; launch experience a plus.
Culture Culture:
Company culture values setting employees up for success and fostering collaborative, solutions-oriented working relationships.
Apply Apply below if this sounds like you!
Details
Seniority level: Director
Employment type: Full-time
Job function: Science
Industries: Pharmaceutical Manufacturing and Biotechnology Research
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr
Director of Regulatory Affairs – Advertising & Promotion
to serve as a Therapeutic Area Lead and regulatory representative for U.S. promotional review. This individual will oversee compliance of promotional materials with FDA regulations, act as the primary point of contact with the FDA’s Office of Prescription Drug Promotion (OPDP), and partner closely with cross‑functional business stakeholders. While this is an individual contributor role, the Director will have oversight and final approval authority for assigned products, managing reviewers within their therapeutic area. This position offers the opportunity to lead a therapeutic area and contribute to shaping strategy, with potential to progress into a more senior leadership position in the future.
Location Location:
Boston, MA (Onsite 3 days/week - you choose what days)
Compensation Base pay range
$225,000.00/yr - $250,000.00/yr
Key Responsibilities
Serve as the
Therapeutic Area Lead
and primary
Regulatory Affairs representative
for assigned products.
Review and approve U.S. promotional materials for compliance with FDA regulations, including OPDP requirements.
Act as the point of contact with the FDA, managing regulatory interactions and submissions as needed.
Partner with Marketing, Legal, Medical Affairs, and other business stakeholders to ensure compliant and effective promotional strategies.
Lead and support the development, maintenance, and implementation of relevant SOPs.
Provide ad/promo compliance guidance and training across the business.
Maintain up-to-date knowledge of industry trends, evolving FDA guidance, and global promotional regulations.
Oversee the work of promotional reviewers within your therapeutic area, ensuring quality and compliance of output.
Qualifications
Bachelor’s degree
required and advanced scientific degree preferred
5+ years of U.S. regulatory advertising & promotion experience
in the pharmaceutical or biotech industry.
Proven expertise in
OPDP interactions , FDA promotional regulations, and global ad/promo standards.
Strong leadership presence with the ability to influence without direct authority.
Exceptional communication skills, with the ability to have constructive yet tough conversations, defend positions, and remain flexible when appropriate.
Collaborative mindset with the ability to build strong, trust-based relationships and find common ground.
Broad therapeutic area experience;
rare disease, oncology, neuroscience, metabolic, or bone
experience preferred but not required.
Experience with both marketed products and pipeline promotional review; launch experience a plus.
Culture Culture:
Company culture values setting employees up for success and fostering collaborative, solutions-oriented working relationships.
Apply Apply below if this sounds like you!
Details
Seniority level: Director
Employment type: Full-time
Job function: Science
Industries: Pharmaceutical Manufacturing and Biotechnology Research
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr