Executive Director, Regulatory CMC Small Molecule New Products

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 youll 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 companys 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 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) divisionsto 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-approvalchanges.

• 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 crossdivisional 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 regulatoryrisk

• 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:

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US and Puerto Rico Residents Only:

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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 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:

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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 anothers thinking and approach problems collectively.

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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 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

$227300.00 - $357900.00

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 employees 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 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

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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 BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.