Senior Specialist, Regulatory Affairs

539

Base: $106,200.00 - $167,200.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
Fda promotional material review
Regulatory risk analysis
Cross-functional collaboration skills
The Senior Specialist, Regulatory Affairs position at Merck involves reviewing and approving US promotional materials while ensuring compliance with FDA regulations and company policies. The role requires collaboration with various teams and offers a hybrid work model, competitive salary, and comprehensive benefits

Job Summary

  • The Senior Specialist is responsible for reviewing and approving US promotional materials while ensuring consistency with regulatory guidelines and company policies.
  • This role requires managing correspondence with the FDA, interpreting advisory comments, and conducting regulatory risk analysis to support business objectives.
  • Candidates will benefit from a comprehensive benefits package including medical, dental, vision, 401(k), and an annual bonus eligibility.

Matching Summary

Match Score: 85

The Senior Specialist, Regulatory Affairs position at Merck involves reviewing and approving US promotional materials while ensuring compliance with FDA regulations and company policies. The role requires collaboration with various teams and offers a hybrid work model, competitive salary, and comprehensive benefits.

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 drug development process
  • Labeling compliance knowledge

Nice-to-have

  • Strategic and analytical thinking
  • Strong verbal and written communication
  • Action oriented approach
  • Negotiation capabilities
  • Policy implementation experience

Key Requirements

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

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter