Senior Specialist, Regulatory Affairs

Merck & Co., Inc.

Base: $106,200.00 - $167,200.00; bonus/equity: ann...
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Fda promotional material review
Regulatory risk analysis
Cross-functional collaboration skills
** Merck & Co., Inc. is seeking a Senior Specialist in Regulatory Affairs who will oversee the review and approval of US promotional materials while collaborating with various departments to ensure compliance with regulatory guidelines. The ideal candidate will have a background in the pharmaceutical or biologics industry and at least two years of relevant experience. **

Job Summary

  • The Senior Specialist is responsible for reviewing and approving US promotional materials while ensuring consistency with regulatory guidelines and company policies.
  • Candidates must manage correspondence with the FDA, interpret advisory comments, and conduct regulatory risk analysis to support business objectives.
  • The role offers a comprehensive benefits package including medical, dental, vision, 401(k), and an annual bonus eligibility within a hybrid work model.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking a Senior Specialist in Regulatory Affairs who will oversee the review and approval of US promotional materials while collaborating with various departments to ensure compliance with regulatory guidelines. The ideal candidate will have a background in the pharmaceutical or biologics industry and at least two years of relevant experience. **

Salary

Base: $106,200.00 - $167,200.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • FDA promotional material review
  • Regulatory risk analysis
  • Cross-functional collaboration skills
  • Understanding of FDA advertising regulations
  • Labeling development knowledge

Nice-to-have

  • Strategic and analytical thinking
  • Strong verbal and written communication
  • Action oriented approach
  • Experience in legal or medical disciplines

Key Requirements

  • B.A. or B.S. degree in science or healthcare
  • Minimum two years' experience in pharmaceutical industry
  • US and Puerto Rico residents only

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter