Executive Director, Regulatory Affairs

Job Description

The Executive Director, Chemistry, Manufacturing, Control for Biologics (Biologics-CMC) is accountable for managing a team of CMC professionals and ensuring rigor in CMC regulatory strategy as well as delivery of high quality CMC submissions for late phase new modality biologics products.  

The Executive Director, as a Senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Control organization (GRACS CMC), will also manage significant projects as an extension of the overall GRACS CMC Leadership Team.  This lead plays a critical role in driving alignment and execution globally across Regulatory CMC (Chemistry, Manufacturing & Controls), GRACS (Global Regulatory Affairs & Clinical Safety), Research and Development (R&D), Manufacturing, and Global Human Health (GHH) to ensure these programs are compliant and available to patients in markets as needed.  

Role reports to Associate Vice President Regulatory CMC.
 
Primary Responsibilities:

• Leads the Regulatory CMC team responsible for our company's antibody-drug conjugates (ADCs) in late-stage development and life cycle management.  

• Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs 

• Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply. 

• 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.  Provides critical review of major submission documents and response to Health Authority questions.

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

• Establishes strong cross-functional and divisional partnerships to ensure collaboration with key stakeholders, customers and external organizations.

• Negotiates with and influences the opinions of others within and across the divisions and regulatory agencies.

• Represent GRACS CMC on key executive level meetings and leadership forums, as a delegate for the CMC Leadership Team member, as required. 

• Actively engage as a Leadership Team member within the regulatory CMC department.

• Monitors changes in regulatory environment with potential strategic impact working closely with Regulatory CMC Policy.

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

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

• Develops plans to execute functional and divisional strategies and initiatives.

• Applies appropriate combination of perspectives (business, technical, global, etc.) when making decisions and generating solutions

• Develops resource requirements and directs the allocation of the resources to meet regulatory CMC deliverables for the team.  Works with R&D, Manufacturing, and GHH to prioritize work within the assigned biologics products to ensure effective support for the portfolio.

•  Partners with R&D, Manufacturing, and GHH to ensure robust prioritization of work to meet agreed upon goals across the organization.  Influences and drives development of innovative solutions to problems and ability to make rapid, disciplined decisions across divisions.

• Manage, coach, and develop CMC staff including performance management and advancement of personal and professional development goals to ensure the team is highly capable of regulatory CMC deliverables required for the biologics portfolio and they are developing broad regulatory CMC capabilities.  Identify key talent and provide development opportunities that enable growth and retain talent.

 
Education:

• Minimum B.S. degree in Biology, Chemistry, Pharmacy, Engineering or other highly relevant area.  Advanced degree (PhD preferred) in Biologics, Pharmaceutical sciences, Engineering or other highly relevant areas.  

 
Required Experience and Skills:

• Minimum of (15) years experience in the Pharmaceutical Industry with direct experience in CMC relevant technical functions.

• Minimum of (10) years’ experience in Regulatory CMC with progressive experience in leading global programs from pre-approval or post-marketing. Direct experience in ADC highly preferred. 

• Minimum of (7) years People Management/ Leadership experience with proven track record of developing talent.  Leadership of larger groups is strongly preferred.

• 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.

• Recognized as a leader with broad expertise in CMC regulatory strategy and dossier management activities across product development, registration and life-cycle management.  Present and influence key topics at Industry/Agency meetings and conferences.

• Experience leading organizational or process related change to drive effective execution and continuous improvement.

• 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

Required Skills:

Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, Chemistry, Collaborative Development, Confidentiality, Cross-Cultural Awareness, Decision Making, Electronic Common Technical Document (eCTD), Executive Management, Mentoring Staff, People Leadership, Pharmaceutical Sciences, Professional Networking, Project Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance Audits, Regulatory Development, Regulatory Monitoring, Regulatory Reporting, Regulatory Risk, Regulatory Submissions, Risk Analysis {+ 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:

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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 another’s 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 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

$255,800.00 - $402,700.00

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:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/23/2026

*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.