Senior Specialist, Regulatory Affairs

29

Base: $106,200.00 - $167,200.00; bonus/equity: ann...
Hybrid (3 days on-site, 1 day remote)
Fda promotional material review
Regulatory risk analysis
Cross-functional collaboration
This job posting is for a Senior Specialist in Regulatory Affairs at a pharmaceutical company, focusing on the review and approval of US promotional materials in compliance with FDA regulations. The role requires collaboration with cross-functional teams and offers a hybrid work model

Job Summary

  • The Senior Specialist is responsible for the review and approval of US promotional materials in collaboration with legal, medical, and commercial colleagues.
  • The role requires developing strategies for FDA promotional submissions and managing correspondence with the FDA regarding advisory comments.
  • Employees are eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

Match Score: 85

This job posting is for a Senior Specialist in Regulatory Affairs at a pharmaceutical company, focusing on the review and approval of US promotional materials in compliance with FDA regulations. The role requires collaboration with cross-functional teams and offers a hybrid work model.

Salary

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

Skills & Requirements

Must-have

  • FDA promotional material review
  • Regulatory risk analysis
  • Cross-functional collaboration
  • FDA regulations understanding
  • Labeling compliance knowledge

Nice-to-have

  • Strategic and analytical thinking
  • Strong verbal communication skills
  • Attention to detail
  • Action oriented approach
  • Negotiation skills

Key Requirements

  • B.A. or B.S. degree in science or healthcare
  • Minimum two years' pharmaceutical industry experience
  • Understanding of FDA advertising and promotion regulations

Work Rights

Not specified

Tailored Resume

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