Executive Director, Regulatory Affairs

Job Description

This position will be responsible for the leadership, oversight and direction for the regulatory review function of US advertising and promotion. This role has ad/promo regulatory review accountabilities across all Therapeutic Areas of our company's portfolio in the US.  This role will manage a team of reviewers and supporting roles to set the strategic direction for a staff of 30+ professionals.  

This executive leadership position has Strategic Responsibilities:

Regulatory Guidance: Interpret and apply advertising and promotion regulations in reviews. Proactively design risk mitigation that anticipates the evolving regulatory landscape and allows for aggressive yet compliant promotional campaigns.

FDA Representation: Act as the primary liaison to the FDA's Office of Prescription Drug Promotion (OPDP) and FDA’s Advertising and Promotional Labeling Branch (APLB), including leading negotiations, interpretations of complex regulations and shaping the dialogue surrounding novel promotional strategies.

Integrated Commercial Strategy Partnership: Function as a partner, providing consultative leadership to cross-functional executive teams (Commercial, Medical and Legal). Ensure seamless integration between regulatory strategy and commercial objectives, ensuring launch and post-approval materials are strategically optimized for market impact from day one. Advise and educate commercial, regulatory, legal, and compliance on regulatory standards, policies and processes for development, review, approval, and dissemination of marketing and promotion materials to ensure they are of the highest quality and are fully compliant with the letter and spirit of relevant laws, FDA regulations and guidance, PhRMA and other industry guidelines, and our company's policies and guidelines.

Leadership & Organizational Development:

• Build and maintain a high-performing team that consistently demonstrates the value of authoritative regulatory guidance on advertising and promotion.

• Develop and maintain a staffing model and resource algorithm that ensures appropriate and effective resources to meet business objectives and priorities.

• Monitor and oversee staff to ensure they are trained on and compliant with all applicable federal health care program requirements, FDA requirements, obligations relevant to any government settlements such as any Corporate Integrity Agreement and/or Consent Decrees and our company policies related to advertising and promotion

• Develop and maintain our company's relationship of trust and respect with FDA OPDP and APLB through constructive, productive, and transparent communications.

• Increase the external impact and influence of our company on shaping regulatory science for the industry by contributing to key discussions and interfacing with professional organizations, consortia, academics, and government agencies on issues related to advertising and promotion.

Education Minimum Requirement: 

• Bachelor of Arts or Science Degree, with advanced degree preferred.  Strongly preferred to have a science-related degree such as biology, chemistry, nursing, pharmacy, social sciences, or QA/regulatory affairs.

Required Experience and Skills:

• Minimum of 15 years biopharmaceutical industry experience in functions of compliance, regulatory strategy, and/or promotion development, with a strong focus on the US review of advertising and promotional materials

• Minimum of 8 years direct experience in reviewing US prescription drug/biologic advertising and promotion materials and marketing programs for regulatory/legal compliance

• Recognized expert in US regulatory advertising and promotion requirements; Demonstrated subject matter expertise in advertising and promotion of FDA-regulated products, including product launches and digital promotion

• In-depth understanding of the clinical development process, including labeling development

• Experience in leading teams and effectively managing staff; At least 5 years managing individual contributors

• Superior skill in analyzing complex regulatory/legal issues and evaluating alternatives and determining risk

• Proven leadership and management skills with cross-functional teams, as well as inspiration and motivational skills

• Superior negotiation and influencing skills, with a proven track record of critical, strategic, independent thinking and problem -solving

• Decisions and actions are always in the best interests of patients, customers and our company and never superseded by organizational politics

• Must have high level of motivation, drive, and demonstration of our company's leadership values

• Excellent written and verbal communication skills, including the ability to write clearly and concisely

• Top-notch interpersonal skills in difficult situations; Ability to work seamlessly with all levels of personnel

• Change Management: Effectively implements procedures or makes decisions to deal with change. Copes with ambiguity in the business environment and leads effectively through ambiguity to keep teams motivated and focused

Required Skills:

Chemistry, Chemistry, Clinical Development, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, FDA Regulations, Innovation, Mentoring Staff, Motivation Management, Organizational Development (OD), People Leadership, Personnel Administration, Pharmaceutical Advertising, Professional Networking, Promotional Strategies, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Regulatory Training, Risk Management and Mitigation, Risk Mitigation Strategies {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$231,900.00 - $365,000.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/27/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.