Associate Director, Regulatory Affairs - Advertising/Promotion (REMOTE)
MannKind Corporation
August 25, 2026
Remote friendly (Boston, MA)
United States
$148,000 - $222,000 USD yearly
Corporate Functions
Job Summary:
The Associate Director, Regulatory Affairs will coordinate and complete regulatory review and approval of all commercial materials, represent the Regulatory team on the Medical Review Committee (MRC) and Promotional Review Committee (PRC), and lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products.
In addition, this role oversees regulatory operational management of commercial materials (Veeva Vault, electronic document management system, applicable processes and SOPs) and prepares required promotional material submissions to regulatory authorities in coordination with Regulatory Operations.
Principal Responsibilities:
- Review, approve, and provide regulatory oversight for product labeling, advertising, promotional materials, and other commercial communications to ensure compliance with FDA regulations, CFR requirements, company policies, and industry standards.
- Lead and manage promotional review processes and operational systems (Veeva Vault PromoMats, document management systems, workflows, SOPs, governance).
- Prepare, compile, and coordinate promotional regulatory submissions, including FDA Form 2253, with Regulatory Operations.
- Develop labeling and promotion strategies for new, existing, and modified products; ensure alignment between approved labeling, promotional messaging, and business objectives.
- Review and approve claims and marketing content for scientific accuracy, claim substantiation, fair balance, risk communication, and consistency with prescribing information.
- Serve as primary regulatory liaison with FDA OPDP and other regulatory authorities; manage agency interactions.
- Participate in FDA meetings, labeling negotiations, and cross-functional discussions.
- Monitor evolving regulations and promotional environment (e.g., OPDP actions, guidance, industry trends) and provide impact recommendations.
- Provide training/education on advertising and promotion regulations, policies, review processes, and compliance expectations.
Qualifications:
- Bachelor’s degree with at least 7 years of Regulatory Affairs and/or Labeling & Advertising Promotional Materials experience in pharmaceuticals.
- Thorough knowledge of FDA regulations/guidelines (including PhRMA) and ability to interpret and apply them to determine applicable requirements.
- Ability to evaluate complex situations/data and translate into clear risk-based recommendations.
- Adaptability to a quickly changing environment.
- Strong communication skills; ability to organize/lead cross-functional meetings and build working relationships.
Pay Range:
$148,000 - $222,000 per hour.
The Associate Director, Regulatory Affairs will coordinate and complete regulatory review and approval of all commercial materials, represent the Regulatory team on the Medical Review Committee (MRC) and Promotional Review Committee (PRC), and lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products.
In addition, this role oversees regulatory operational management of commercial materials (Veeva Vault, electronic document management system, applicable processes and SOPs) and prepares required promotional material submissions to regulatory authorities in coordination with Regulatory Operations.
Principal Responsibilities:
- Review, approve, and provide regulatory oversight for product labeling, advertising, promotional materials, and other commercial communications to ensure compliance with FDA regulations, CFR requirements, company policies, and industry standards.
- Lead and manage promotional review processes and operational systems (Veeva Vault PromoMats, document management systems, workflows, SOPs, governance).
- Prepare, compile, and coordinate promotional regulatory submissions, including FDA Form 2253, with Regulatory Operations.
- Develop labeling and promotion strategies for new, existing, and modified products; ensure alignment between approved labeling, promotional messaging, and business objectives.
- Review and approve claims and marketing content for scientific accuracy, claim substantiation, fair balance, risk communication, and consistency with prescribing information.
- Serve as primary regulatory liaison with FDA OPDP and other regulatory authorities; manage agency interactions.
- Participate in FDA meetings, labeling negotiations, and cross-functional discussions.
- Monitor evolving regulations and promotional environment (e.g., OPDP actions, guidance, industry trends) and provide impact recommendations.
- Provide training/education on advertising and promotion regulations, policies, review processes, and compliance expectations.
Qualifications:
- Bachelor’s degree with at least 7 years of Regulatory Affairs and/or Labeling & Advertising Promotional Materials experience in pharmaceuticals.
- Thorough knowledge of FDA regulations/guidelines (including PhRMA) and ability to interpret and apply them to determine applicable requirements.
- Ability to evaluate complex situations/data and translate into clear risk-based recommendations.
- Adaptability to a quickly changing environment.
- Strong communication skills; ability to organize/lead cross-functional meetings and build working relationships.
Pay Range:
$148,000 - $222,000 per hour.