Executive Director, Digital Regulatory and Safety

Job Description

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world.

Reporting to the Associate Vice President, Clinical and Development Digital Solutions (CDDS IT), the Executive Director, Digital Regulatory and Safety, will lead our efforts in transforming regulatory submissions and pharmacovigilance through modern platforms and responsible generative AI.

Primary Responsibilities:

• Develop and promote a multiyear product strategy for Digital Regulatory & Safety, aligning with IT and Research and Development (R&D) priorities, including prioritized roadmaps and investment cases to deliver enterprise value, focusing on innovation, risk, regulatory compliance, and scalability.
• Act as a senior technology business partner to various stakeholders, translating strategic needs into product investments.
• Define and drive adoption of target-state architecture and reusable capability layers across Regulatory and Pharmacovigilance, with a focus on integrated platforms and thoughtful end to end capabilities
• Lead the responsible adoption of generative AI technologies for regulatory authoring and translations across R&D, partnering with enterprise technology teams, Legal and Compliance
• Develop and support the practice of product management, building the mindset and practice of end-to-end accountability of product lifecycle, resolving uncertainty early through product discovery and agile practices, and identification of reusable patterns that enable scale and efficiency in product delivery.
• Build and scale a high-performing product organization, manage a group of 40-60 technology professionals, promoting career development and continuous upskilling of talent to build incredible teams and the ecosystem to empower them.
• Develop an external presence and strong internal networks to recruit highly skilled and diverse talent, stay current with industry trends, and establish effective vendor partnerships

Education:

• Bachelor's degree in IT, computer science, life sciences, or related discipline; advanced degree preferred.

Required Experience and Skills:

• 12+ years of progressive technology/product leadership in pharmaceutical, biotech, or regulated life sciences.
• 5+ years of experience in technology enablement for regulatory or safety, with management responsibilities.
• Proven track record in setting and delivering product strategy in regulatory affairs and pharmacovigilance domains, with an ability to execute consistently, rapidly, and effectively.
• undefined
• Outstanding interpersonal and communication skills; adept at working with colleagues from diverse disciplines and at all levels of the company, articulating complex technical topics at the right level of detail for specific audiences.
• Proven experience in team building, mentoring, and leadership with a demonstrated ability to inspire others to follow a common vision.
• Excellent stakeholder management, communication, and influencing skills at senior levels across global organizations.
• Experience managing strategic vendor relationships and third-party platform implementations.

Preferred Experience and Skills:

• Experience with Veeva (Vault Regulatory, Vault Docs) or equivalent regulatory authoring/publishing platforms.
• Demonstrated experience delivering regulatory affairs and pharmacovigilance technology solutions (authoring/publishing, PV case management/reporting, labeling/registrations, translations).
• Hands-on experience with LLM-based enterprise applications for authoring or translation.
• Experience with enterprise AI/ML programs, including generative AI/LLM applications and model governance in regulated contexts.

Required Skills:

Asset Management, Benefits Management, Communication, Computer Science, Digital Strategy, Generative AI, Immunochemistry, Life Science, Management Process, Management System Development, Product Management, Product Management Leadership, Product Strategies, Regulatory Affairs Compliance, Regulatory Compliance, Requirements Management, Stakeholder Communications, Stakeholder Relationship Management, Strategic Planning, System Designs, Veeva Vault

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

$227, $357,900.00

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

You can apply for this role through (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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

NA

Job Posting End Date:

11/18/2025

• 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.

Requisition ID:R372154