Job Description

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Executive Director, Chemistry, Manufacturing & Controls (CMC), Pre-approval Pharm will bring scientific and regulatory expertise, innovative approaches, and strong industry and FDA connections to our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high-quality submissions for products that may include respiratory/ inhalation, peptide, antibody-drug conjugates (ADCs), and traditional solid-oral small molecules.

The Executive Director will help drive our company's growth into new modalities and innovative approaches with FDA and other regulatory authorities. This role will also be a lead and advocate for digital innovation and leveraging it for how we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC organization and will also manage significant cross-modality projects as an extension of the overall Regulatory Affairs CMC Leadership Team. This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC (Global Regulatory Affairs & Clinical Safety), Research and Development (R&D), Manufacturing, and Global Human Health (GHH) divisions to ensure these programs are compliant and available to patients in markets as needed.

Primary Responsibilities:

• Lead a small team of CMC regulatory scientists responsible for new modality or traditional solid-oral small molecules and includes pre-approval regulatory strategy and submissions (global clinical and marketing applications such as IND, CTA, NDA, and MAA) and limited CMC post-approval changes.

• Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and the Head of CMC External Advocacy in Manufacturing Quality, to monitor changes in regulatory environment with potential strategic impact and drive innovative regulatory approaches globally.

• Act as CMC strategy lead for digital initiatives impacting the CMC Regulatory space including internal and external digital efforts, such as generative AI authoring, Accumulus, SPQS, and Digital CMC.

• Serves as the CMC Regulatory Affairs representative and active Leadership Team member in executive forums, driving the development and implementation of CMC regulatory strategy and plans for assigned projects/products.

• Effectively communicates CMC regulatory strategy, risk, mitigation, and overall plan to the Regulatory Affairs, R&D, Manufacturing and GHH management teams, product development teams, and executive management.

• Establishes strong cross-functional and divisional relationships with key stakeholders, customers, and external organizations.

• Performs risk assessments for determination of probability of success for strategic regulatory CMC decisions, approves appropriate level of risk and mitigation for significant issues.

• Ensures that all regulatory requirements are met and that systems are used appropriately to ensure proper product control. Ensures appropriate reviews, approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with Health Authorities.

• Evaluates key business challenges of products/programs within the franchise and collaborates with team members to direct the development of new and improved solutions.

• Defines resource requirements and directs their allocation to meet the profit plan, partnering with Manufacturing, R&D, and GHH Sales & Marketing to prioritize work, drive cross‑divisional decisions, and develop innovative solutions that achieve agreed organizational goals.

Education:

• Advanced scientific degree (MS or PhD) in Biology, Chemistry, Pharmacy, Engineering or other highly relevant area with a minimum of (12) years’ experience in the Pharmaceutical Industry

Required Experience and Skills:

• Minimum of (10) years’ experience in Regulatory CMC leading global programs with a focus on respiratory/inhalation, peptide, antibody-drug conjugates (ADCs), and traditional solid-oral small molecule products and including pre-approval regulatory work (global clinical and marketing applications such as IND, CTA, NDA, and MAA) and limited CMC post-approval change support.

• Minimum of (7) years of significant People Management / Leadership experience with proven track record of developing talent.

• Recognized as a leader both internally and externally with broad expertise in CMC regulatory strategy and dossier management activities across product development, registration, and life-cycle management.

• A strong track record of engagement and presenting/influencing key topics at Industry/Agency meetings and conferences.

• Direct involvement in industry efforts on digital regulatory initiatives.

• Demonstrated ability to anticipate and influence within and across divisions/business units and in the external business and regulatory environment to identify potential challenges impacting the business and proactively recommend approaches to minimize regulatory risk

• Demonstrated ability to recruit, train and develop staff, to motivate others and drive continuous improvement.

• Flexibility to operate in a matrix-managed environment and to support staff in that same environment.

• 10% Travel

#gracs

Required Skills:

Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biochemistry, Cross-Cultural Awareness, Customer Problem Solving, Documentation Standards, Document Control Systems, Driving Continuous Improvement, Electronic Common Technical Document (eCTD), Executive Business Management, Immunochemistry, Influence, Innovation, Interpersonal Relationships, Manufacturing Compliance, Mentoring Staff, People Management, Pharmaceutical Management, Professional Networking, Regulatory Communications, Regulatory Compliance Audits, Regulatory Requirements, Regulatory Strategy Development, Research Development, Risk Analysis {+ 1 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

$227,300.00 - $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 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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

n/a

Job Posting End Date:

10/14/2025

*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.