Job Description
This Role is responsible for developing and implementing Chemistry, Manufacturing and Control regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies, in addition to the preparation and review of information required for development of regulatory Chemistry, Manufacturing and Control dossiers for commercial products.
Regulatory Responsibilities:
Lead global product and project regulatory strategies by identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
Execute regulatory strategies by leading the development, authoring and review of Chemistry, Manufacturing and Control submission components and documentation to support approval supplements/variations, Drug Master Files, New Drug Application/Biologics License Application/Marketing Authorization Application, Annual Reports, Commitment and responses to health authority questions
Liaise with global Chemistry, Manufacturing and Control, Manufacturing Division and external partners including Contract Manufacturing Organizations tosupport compliant execution of change management and conduct all activitieswith an unwavering focus on regulatory conformance.
Assess and communicate potential regulatory risks and propose mitigation strategies.
Deliver all regulatory milestones for assigned products across the productlifecycle
Technical Skills:
Experience in reviewing scientific information to assess technical merits andsuitability of scientific rationale to ensure information is presented clearly andconclusions are adequately supported by data.
Demonstrated oral and written communication skills and the ability tocommunicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields (e.g., manufacturing, analytical testing, and quality assurance).
Proficient computer skills and previously demonstrated ability to operate inelectronic document based GMP systemsincluding Veeva.
Leadership Skills:
Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities or dealing withunexpected events.
Capability to handle multiple priorities and balance work to achieve business goals.
Demonstrated effective leadership, communication, and interpersonal skills
Qualifications & Skills:
Bachelor's in science, Engineering, or a related field (advanced degreepreferred but not required). Fields of study include Pharmacy, ChemicalEngineering, Biology, Microbiology, Virology, Molecular Biology, orBiochemistry
Preferred: At least 5 years pharmaceutical industry experience, or up to 3 years' experience in managing Chemistry, Manufacturing and Control Regulatory submissions for small molecules/vaccines/biologics. Experience in Veeva.
Required Skills:
Adaptability, Biologics License Application (BLA), Cross-Cultural Awareness, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, International Regulatory Compliance, Pharmaceutical Process Development, Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory Submissions, Regulatory Writing, Strategic Thinking, Technical Writing
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
The salary range for this role is
$142,400.00 - $224,100.00
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 s 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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/9/2026
*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.
