Executive Director, Regulatory Affairs, Advertising and Promotion
Boehringer Ingelheim, Ridgefield, CT, United States
Description
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Executive Director, Regulatory Affairs, Advertising and Promotion ensures regulatory compliance of BI’s promotional communications while enabling business objectives. The role provides strategic leadership across promotional review governance, shapes internal policy through participation in the Human Pharmaceuticals Review Committee, and strengthens regulatory intelligence through cross‑functional and external partnerships. The Executive Director oversees and develops a team of regulatory professionals specializing in Rx drug advertising and promotion, representing the function within the Regulatory Affairs leadership team and supporting global discussions, training, and alignment on U.S. FDA promotional requirements.
Duties & Responsibilities
Leads, develops, evaluates, and retains high‑performing regulatory professionals who support the regulatory review of Rx drug advertising and promotion
Determines regulatory risk strategies for BI drug and biologic promotion
Participates in HPRC meetings and strategic discussions related to risk assessment for promotional materials
Assess regulatory risk by applying enforcement history, regulatory guidance, market trends, and other intelligence sources
Participates in multi‑functional teams that develop internal policies and procedures related to Rx drug promotion
Identifies and addresses process or procedural gaps that impact efficiency and quality in advertising and promotional labeling
Mentors Regulatory Affairs Ad/Promo team members, supports development planning, and provides meaningful assignments that promote growth
Represents U.S. Ad/Promo regulatory interests in discussions with global colleagues on promotional tactics
Ensures global promotional tactics intended for U.S. markets comply with FDCA requirements and FDA expectations
Serves as the Regulatory Affairs representative in Line Management Escalation meetings for promotional materials
Participates in senior management escalation meetings, ensuring decisions balance regulatory guardrails with business needs
Applies deep knowledge of FDCA, 21 CFR regulations, and FDA promotional guidance to evaluate promotional claims
Balances regulatory requirements with business needs to support compliant promotional communication
Requirements
Bachelor’s degree in life sciences or a legal field; advanced degree preferred
Candidates with non‑science degrees may qualify with relevant professional experience
Minimum 8–10 years of pharmaceutical industry experience, including substantial Regulatory Affairs experience
Strong knowledge of Rx drug development, the FDCA, and 21 CFR regulations related to drug promotion
Ability to self‑direct workload, reprioritize effectively, and meet deadlines
Ability to analyze and interpret scientific data and regulatory guidelines to apply appropriate risk‑assessment principles Demonstrated competence in conflict resolution and ability to work toward consensus in cross‑functional settings
Previous direct managerial experience with demonstrated leadership capabilities preferred
Strong written and verbal communication skills, including comfort with public speaking, presentations, and training delivery
Eligibility Requirements
Must be legally authorized to work in the United States without restriction
Must be willing to take a drug test and post‑offer physical (if required)
Must be 18 years of age or older
Compensation This position offers a base salary typically between $250,000 and $394,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
Our Company
Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.
Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
Want to learn more? Visit https://www.boehringer-ingelheim.com
#J-18808-Ljbffr
The Executive Director, Regulatory Affairs, Advertising and Promotion ensures regulatory compliance of BI’s promotional communications while enabling business objectives. The role provides strategic leadership across promotional review governance, shapes internal policy through participation in the Human Pharmaceuticals Review Committee, and strengthens regulatory intelligence through cross‑functional and external partnerships. The Executive Director oversees and develops a team of regulatory professionals specializing in Rx drug advertising and promotion, representing the function within the Regulatory Affairs leadership team and supporting global discussions, training, and alignment on U.S. FDA promotional requirements.
Duties & Responsibilities
Leads, develops, evaluates, and retains high‑performing regulatory professionals who support the regulatory review of Rx drug advertising and promotion
Determines regulatory risk strategies for BI drug and biologic promotion
Participates in HPRC meetings and strategic discussions related to risk assessment for promotional materials
Assess regulatory risk by applying enforcement history, regulatory guidance, market trends, and other intelligence sources
Participates in multi‑functional teams that develop internal policies and procedures related to Rx drug promotion
Identifies and addresses process or procedural gaps that impact efficiency and quality in advertising and promotional labeling
Mentors Regulatory Affairs Ad/Promo team members, supports development planning, and provides meaningful assignments that promote growth
Represents U.S. Ad/Promo regulatory interests in discussions with global colleagues on promotional tactics
Ensures global promotional tactics intended for U.S. markets comply with FDCA requirements and FDA expectations
Serves as the Regulatory Affairs representative in Line Management Escalation meetings for promotional materials
Participates in senior management escalation meetings, ensuring decisions balance regulatory guardrails with business needs
Applies deep knowledge of FDCA, 21 CFR regulations, and FDA promotional guidance to evaluate promotional claims
Balances regulatory requirements with business needs to support compliant promotional communication
Requirements
Bachelor’s degree in life sciences or a legal field; advanced degree preferred
Candidates with non‑science degrees may qualify with relevant professional experience
Minimum 8–10 years of pharmaceutical industry experience, including substantial Regulatory Affairs experience
Strong knowledge of Rx drug development, the FDCA, and 21 CFR regulations related to drug promotion
Ability to self‑direct workload, reprioritize effectively, and meet deadlines
Ability to analyze and interpret scientific data and regulatory guidelines to apply appropriate risk‑assessment principles Demonstrated competence in conflict resolution and ability to work toward consensus in cross‑functional settings
Previous direct managerial experience with demonstrated leadership capabilities preferred
Strong written and verbal communication skills, including comfort with public speaking, presentations, and training delivery
Eligibility Requirements
Must be legally authorized to work in the United States without restriction
Must be willing to take a drug test and post‑offer physical (if required)
Must be 18 years of age or older
Compensation This position offers a base salary typically between $250,000 and $394,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
Our Company
Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.
Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
Want to learn more? Visit https://www.boehringer-ingelheim.com
#J-18808-Ljbffr