MSD

Associate Principal Scientist, Regulatory Affairs – CMC

MSD

full-time

Posted on:

Location Type: Hybrid

Location: Rahway • Maryland • New Jersey • United States

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Salary

💰 $142,400 - $224,100 per year

Job Level

Lead

About the role

  • Responsible for developing and implementing CMC regulatory strategies for pharmaceutical pipeline products
  • Serve as a CMC Product Lead for assigned products
  • Lead development and execution of global product and project regulatory strategy(ices)
  • Manage execution of CMC documentation including IND/CTA, original NDA/MAA
  • Prepare and communicate CMC Risk Assessments, contingency plans, lessons learned, and escalate potential regulatory issues to management
  • Partner with quality colleagues to prepare for and support pre-approval and regulatory inspections

Requirements

  • B.S. in a biological science, engineering, or a related field (advanced degree preferred)
  • At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields
  • Proficient in English; additional language skills are a plus.
  • Experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills
  • Regulatory CMC experience with complex drug-device combination products/ inhalation products including nebulizers, dry powder inhalers and metered dose inhalers is required
  • Familiarity with the latest global regulatory guidance’s and pharmacopeial methods
  • Ability to develop innovative and imaginative approaches to problem solving
  • Excellent interpersonal, verbal, and written communication, presentation, and listening skills
Benefits
  • 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
  • annual bonus and long-term incentive, if applicable
Applicant Tracking System Keywords

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

Hard Skills & Tools
CMC regulatory strategiesIND/CTA documentationNDA/MAA documentationregulatory filingsdrug-device combination productsinhalation productsnebulizersdry powder inhalersmetered dose inhalerspharmacopeial methods
Soft Skills
problem solvinginterpersonal skillsverbal communicationwritten communicationpresentation skillslistening skillstechnical leadership