Principal Scientist – Regulatory Affairs, CMC

MSD

Principal Scientist managing Regulatory Affairs-CMC for small molecule respiratory products. Leading a team to develop regulatory strategies and oversee submissions compliant with global regulations.

Posted 5/17/2026full-timeRahway • Maryland, New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $190,800 - $300,300 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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, and a minimum of 3 years managing people.
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 have a comprehensive knowledge of the latest global regulatory guidance and pharmacopeial methods with a demonstrated ability to apply them to building regulatory strategies related to Inhalation products.
The candidate should have a good understanding of characterization studies and key analytical methods used for inhalation products.
The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
Must have a depth of experience in defining global Regulatory CMC strategy, 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 & written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts.
The candidate must have demonstrated experience in building, rewarding, and retaining key talent.
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.

Benefits

Comp & perks

medical
dental
vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Regulatory CMCIND submissionsCTA submissionsWorldwide Marketing Applicationsregulatory strategiescharacterization studiesanalytical methodsdrug-device combination productsinhalation productspharmacopeial methods

Soft Skills

leadershipcollaborationcritical thinkingproblem solvingcommunicationpresentationinterpersonal skillsdecision makingtalent developmentflexibility

Certifications

Master's degree in chemistryMaster's degree in Pharmacypost-graduate degree