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Manager/Sr Associate Regulatory Affairs Specialist

5+ years
Not Disclosed
10 Jan. 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Submissions Manager Assistant (Reg Spec III)
Location: Labcorp (Full-Time Role)

Labcorp is looking for a Regulatory Submissions Manager Assistant to support the development of client products and manage multi-functional regulatory projects. This position provides the opportunity to collaborate with senior leadership, finance, and PMO teams to ensure the success of regulatory submission projects. If you have experience in Regulatory Affairs, Drug Development, or Medical Device Development, and a passion for leading teams and improving processes, this could be the perfect role for you.


Essential Job Duties

  • Manage multi-functional regulatory projects and participate in cross-functional initiatives.
  • Lead proposal and bid defense efforts for regulatory projects.
  • Lead Product Development Teams (multidisciplinary teams) for client relationships and drug development goals.
  • Contribute to GRA materials for proposals, training, and capabilities content.
  • Identify and implement best practices to drive sustainable competitive advantage for regulatory affairs.
  • Collaborate with CTMO and GRA Leadership to recommend and lead improvements in operational performance.
  • Support business development activities to increase regulatory services business and molecule development work.
  • Perform other duties as assigned by GRA Leadership.

Experience and Qualifications

  • Minimum Required:
    • Master’s Degree in Life Sciences or equivalent.
    • At least 5 years of experience in Pharmaceutical, IVD, MD, or Drug Development industries, specifically in Regulatory Affairs, Medical Device Development, or Diagnostic Drug Development.
    • Proficiency in both English and Japanese (spoken and written) at a business level.

Why Labcorp?

Labcorp is committed to helping our clients and employees grow through collaboration and innovation. As an Equal Opportunity Employer, Labcorp embraces diversity and is dedicated to providing opportunities to everyone regardless of background. We are proud to foster a culture where all individuals are valued.


Benefits:

  • Comprehensive Benefits Package for full-time employees.
  • Medical, Dental, Vision, Life Insurance
  • 401(k) plan with company match
  • Paid Time Off (PTO) or Flexible Time Off (FTO)
  • Tuition Reimbursement and Employee Stock Purchase Plan

Labcorp is proud to be an Equal Opportunity Employer. We encourage all to apply.

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