Merck · 8 hours ago
Associate Principal Scientist (Assoc. Director), Regulatory Affairs - CMC
Rahway, NJ
Full-time
Hybrid
Senior Level, Lead/Staff
$142K/yr - $224K/yr
5+ years expMerck is a leading global healthcare company dedicated to improving health and well-being. The Associate Principal Scientist will be responsible for developing and implementing regulatory strategies for pharmaceutical pipeline products with a focus on respiratory/inhalation product development, ensuring compliance with global regulations.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product & device development requirements and strategies including assessment of the probability of regulatory success together with risk mitigation measures
Lead development and execution of global product and project regulatory strategy(ices) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks
Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects
Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team
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
Prepare and communicate CMC Risk Assessments, contingency plans, lessons learned, and escalate potential regulatory issues to GRACS CMC management, as needed
Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, CRO/CMOs) to execute program objectives in compliance with applicable regulations
Partner with our quality colleagues to prepare for and support pre-approval and regulatory inspections, ensuring launch readiness and regulatory success
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's pharmaceutical products worldwide
Conduct all activities with an unwavering focus on compliance
Qualification
Required
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
At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields
The candidate must be proficient in English; additional language skills are a plus
Biochemistry
Biological Sciences
Biologics License Application (BLA)
Chemical Engineering
Documentations
Dry Powder Inhalers (DPI)
Electronic Common Technical Document (eCTD)
Immunochemistry
International Regulatory Compliance
Microbiology
Molecular Microbiology
Pharmaceutical Process Development
Pharmaceutical Research
Regulatory CMC
Regulatory Compliance
Regulatory Strategy Development
Regulatory Submissions
Regulatory Writing
Technical Leadership
Preferred
The ideal candidate will have experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)
Regulatory CMC experience with complex drug-device combination products/ inhalation products including nebulizers, dry powder inhalers and metered dose inhalers is required
Preferably, the candidates should be familiar with the latest global regulatory guidance's and pharmacopeial methods with a demonstrated ability to apply them to build regulatory strategies related to Inhalation products
The candidate must demonstrate the ability to develop innovative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events
They must have superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role
The candidate must have excellent interpersonal, verbal, and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams
They must have proven experience in critically reviewing detailed scientific information and assessing the technical arguments presented with clear and concise conclusions adequately supported by data
The candidate must be proficient in English; additional language skills are a plus
Inhalers
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-24
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