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Executive Director, Regulatory Affairs, Advertising and Promotion

Boehringer Ingelheim

Ridgefield, CT

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JOB DETAILS
SALARY
$250,000–$394,000 Per Year
SKILLS
Advertising, Analysis Skills, Biology, Biotech and Pharmaceutical, Business Intelligence, Code of Federal Regulations, Communication Skills, Compensation and Benefits, Conflict Resolution, Drug Development, FDA Requirements, Leadership, Legal, Maintain Compliance, Market Trend Analysis, Materials Analysis, Mentoring, Policy Development, Prescription Drugs, Presentation/Verbal Skills, Procedure Development, Promotional Strategy, Regulations, Regulatory Requirements, Risk, Risk Analysis, Safety/Work Safety, Time Management, Training/Teaching, Writing Skills
LOCATION
Ridgefield, CT
POSTED
30+ days ago
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.

+ Assesses 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. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

About the Company

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Boehringer Ingelheim