Merck · 9 hours ago
Principal Scientist (Director), Regulatory Affairs-CMC
Rahway, NJ
Full-time
Hybrid
Lead/Staff, Director/Executive
$191K/yr - $300K/yr
15+ years expMerck is a leading pharmaceutical company focused on developing innovative products. The Principal Scientist in Regulatory Affairs-CMC will be responsible for developing and implementing regulatory strategies for pharmaceutical pipeline products, particularly in the respiratory and inhalation domains.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Provide regulatory leadership, oversight, and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule, development products. This includes preparation of applicable IND/CTA’s, Agency Background Packages, Worldwide Marketing Applications (including Most of World applications), and transfer strategy to post-approval grp. for further submissions occurring within several years post-launch in the major markets
This role may also directly support a project in a similar capacity; however, the primary focus of the position is providing direction to the team members that are responsible for developing and overseeing implementation of regulatory strategies, and making decisions that ensure high quality, accuracy, and high likelihood of approval of all regulatory submissions. This includes assessing CMC changes during development, defining regulatory requirements, developing CMC regulatory strategies demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, understanding the impact to the business, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment
Be responsible for proactive and timely communication of regulatory risks, challenges, and opportunities to management to help address them in a systematic and thoughtful manner. Develop, execute & provide oversight of regulatory initiatives & strategies of significant complexity and apply exceptional ingenuity to solve problems and mitigate potential regulatory challenges. Drive the application of regulatory strategies and concepts across multiple disciplines and multiple organizations, including working directly with Senior Leadership in these areas. Embody our Company's Values and Leadership Behaviors in day-to-day activities and serve as an example by practicing them consistently
Continuously evaluate and develop talent within the team and prepare a succession plan. Use recognition and rewards to promote team and organizational collaboration. Set a vision for the team and hold employees accountable for the execution of departmental policies and procedures. Manage resources and prioritization within assigned areas. Actively sponsor employees who lead and participate in our Company's initiatives. Develop strong collaborative relationships with stakeholders and partners across the organization. Represent the department’s needs and positions in senior leadership forums. Develop and maintain expert knowledge of current global regulatory CMC requirements for IND/CTA submissions, and original registrations. Identify and resolve technical and operational problems associated with regulatory strategy and submissions using rapid, disciplined decision making; collaborate with peers to resolve cross-functional obstacles using excellent critical thinking skills. Candidates should have the ability to adapt to change and work in a fast-paced, demanding environment. Establish, refine, and ensure adherence to internal regulatory SOPs to optimize operational efficiency and compliance. Partners with Quality colleagues strategically prepare for and lead pre-approval and regulatory inspections, ensuring launch readiness and regulatory success. Champion a culture of continuous improvement, driving operational excellence and innovation in regulatory process and cross-functional collaboration
Look for innovative and scientifically sound approaches to gain approval of new products. Participate in the development of CMC business processes or organizational initiatives as needed. Lead the Regulatory CMC discussions and interactions with regulatory agencies to facilitate review and approval of submissions. Develop and maintain an expert knowledge of Industry Association Whitepapers, Health Authority regulations & guidance documents. Utilize expert knowledge and reputation to influence the content of new Industry Association Whitepapers, Health Authority guidance & regulations. Present and participate at industry meetings
Qualification
Required
Master's degree in chemistry, Pharmacy, or a related discipline; post-graduate degree preferred
Minimum 15 years pharmaceutical industry experience; 10 years with an advanced degree
Minimum 5 years working in Regulatory CMC, including the development stages of the product life cycle
Minimum of 3 years managing people
Audits Compliance, CMC Development, Data Integrity, Documentations, Dry Powder Inhalers (DPI), Employee Training Programs, Organizational Optimization, Pharmaceutical Process Development, Pharmacology, Production Optimization, Product Lifecycle, Regulatory CMC, Regulatory Compliance, Regulatory Experience, Technical Writing
Preferred
Strong experience in Regulatory CMC with strong technical leadership skills
Demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)
Experience managing a team of Regulatory CMC professionals
Regulatory CMC experience with complex drug-device combination products/ inhalation products including nebulizers, dry powder inhalers and metered dose inhalers
Comprehensive knowledge of the latest global regulatory guidance and pharmacopeial methods
Good understanding of characterization studies and key analytical methods used for inhalation products
Ability to develop creative and imaginative approaches to problem solving
Ability to flexibly respond to changing priorities or unexpected events
Depth of experience in defining global Regulatory CMC strategy
Superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities
Excellent interpersonal, verbal & written communication, presentation, and listening skills
Proven record of working with, and influencing, multi-disciplinary teams and external experts
Demonstrated experience in building, rewarding, and retaining key talent
Proven experience in critically reviewing detailed scientific information and assessing the technical arguments presented
Proficient in English; additional language skills are a plus
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
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