Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control

Job Description

Senior Scientist (R3) REGULATORY CMC BIOLOGICS

Position Description:

• Serve as a Regulatory Chemistry Manufacturing and Control (CMC) Project Lead and provide CMC leadership within Regulatory and on cross-functional teams for the assigned biological projects. Be accountable for the delivery of all regulatory milestones through product development and / or post approval life cycle.
• Ensure development of robust CMC regulatory strategies for assigned projects. Be accountable for the execution of global product regulatory strategy(ies) by robust assessment of global regulatory Chemistry Manufacturing and Control requirements and identification of potential risks.
• Manage execution of CMC documentation including Investigational New Drug Applications Investigational Medicinal Product Dossiers original Biologics License Applications Marketing Authorization Applications or Post approval / variations agency background packages and responses to health authority questions per established business processes and systems.
• Identify communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety Chemistry Manufacturing and Control management as needed
• Conduct all activities with an unwavering focus on compliance

Position Qualifications:

Education Minimum Requirement:

• B.S. in a science engineering or a related field (advanced degree preferred). Fields of study include Chemical Engineering Biology Microbiology Virology Molecular Biology or Biochemistry.

Required Experience and Skills:

• 5 years of Regulatory CMC related experience relevant experience including biological or vaccine drug substance/drug product development research or manufacturing testing and/or related field.

Preferred Experience and Skills:

• Experience in biologics Regulatory CMC preferred.

Required Skills:

Adaptability Adaptability Biologics Biology Biotechnology Detail-Oriented Document Coordination Electronic Common Technical Document (eCTD) Employee Training Programs Interpersonal Relationships Legal Compliance Operational Compliance Pharmaceutical Industry Pharmaceutics Product Compliance Regulatory Affairs Management Regulatory CMC Regulatory Communications Regulatory Compliance Regulatory Compliance Audits Regulatory Documents Regulatory Experience Regulatory Interpretation Regulatory Management Regulatory Operations 6 more

Preferred Skills:

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The salary range for this role is

$117000.00 - $184200.00

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/14/2026

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