Job Description
The Regulatory CMC Principal Scientist is responsible for developing and implementing CMC regulatory strategies for pharmaceutical products in accordance with global regulations, guidance, and our company’s procedures. He/she will lead the preparation and submission of CMC dossiers to support global market applications.
Primary responsibilities include, but are not limited to:
Responsibilities:
- Serve as a CMC Product Lead for new small molecule and peptide pharmaceutical products and be accountable for the delivery of all regulatory milestones throughout product development including assessment of the probability of regulatory success together with risk mitigation measures.
- Lead the Regulatory CMC discussions and interactions with regulatory agencies to facilitate review and approval of new product submissions.
- Provide regulatory leadership, oversight, and strategy to a matrixed team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule and peptide development products. This includes preparation of applicable IND/CTAs, Agency Background Packages, and Worldwide Marketing Applications (including Most of World applications).
- Provide regulatory leadership as needed in product in-license/due diligence review
- Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
- Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed.
- Continuously evaluate and develop talent within the team and prepare a succession plan.
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of our company pharmaceutical products worldwide.
- Conduct all activities with an unwavering focus on compliance.
Technical Skills:
- Proven experience in regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
- Demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
- Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data is required.
- In-depth of experience in defining global CMC strategy and must have collaboration and decision-making capabilities to be successful in this role.
- Subject Matter Expertise in a pharmaceutical-related discipline.
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
Leadership Skills:
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Demonstrated effective leadership, communication, interpersonal and negotiating skills.
- Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
Qualifications
- B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry
- 5-10 years of pharmaceutical development experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields.
- At least 7 years' experience in Regulatory CMC roles, leading the preparation of NDA/MAA CTD content.
- The candidate must be proficient in English; additional language skills are a plus.
Required Skills:
Adaptability, Audits Compliance, Biotechnology, Change Management, Confidentiality, Cross-Cultural Awareness, Decision Making, Drug Development, Employee Training Programs, Legal Compliance, Life Cycle Support, Pharmaceutical Products, Regulatory Affairs Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Management, Regulatory Processes, Regulatory Research, Regulatory Strategies, Regulatory Submissions, Technical Writing, Timeline Management
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
The salary range for this role is
$190,800.00 - $300,300.00
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:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
09/25/2026
*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.
