Associate Director, Regulatory Liaison – Oncology

MSD

Associate Director in Regulatory Affairs for Oncology, supporting global registration strategies and regulatory submissions. Collaborating with cross-functional teams to ensure compliance and successful product development.

Posted 5/29/2026full-timeRahway • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $142,400 - $224,100 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

regulatory submissionsmarketing applicationsinvestigational new drug (IND) applicationsregulatory strategyprocess improvementdrug developmentregulatory agency communicationscompetitive intelligencescientific researchguideline review

Soft Skills

communication skillsorganizational skillsattention to detailflexibilityanalytical skillsability to balance multiple projectsteam collaborationproblem-solvinginterpersonal skillsactive participation

Certifications & Qualifications

M.D.Ph.D.Master’s DegreeBachelor’s Degree

Industry Keywords

Oncologypharmaceutical industryregulatory teamglobal strategyAgency background packagesAgency meetingsregulatory precedencepediatric plansannual reportsregulatory experience

About the role

Key responsibilities & impact

Supports products in the Oncology therapeutic area as part of a regulatory team
Work closely with a global regulatory lead(s) to help develop and implement a global strategy for registration and/or maintenance of products
Assisting in Regulatory Agency communications and submissions, including marketing applications, investigational new drug (IND) applications, pediatric plans and annual or other periodic reports
Implementing strategy to develop Agency background packages and documents associated with regulatory submissions for marketing applications
Communicating with Agencies and attending Agency meetings as needed
Participating as an active member on the global regulatory team
Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy
Assisting with process improvement initiative
Performing regulatory administrative activities, as needed

Requirements

What you’ll need

M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline
Master’s Degree with at least 2 years of relevant experience in pharmaceutical industry
Bachelor’s Degree, with at least 5 years of relevant experience in the pharmaceutical industry
Experience in drug development
Prior regulatory experience interacting with a major regulatory agency
Excellent communication skills (both oral and written)
Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects
Flexibility required
Strong scientific and analytical skills with attention to detail

Benefits

Comp & perks

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