Senior Specialist, Regulatory Affairs
About The Position
The Senior Specialist is responsible for the review and approval of US promotional materials. As a member of the Review Team, work collaboratively with legal, medical, and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company policies, and support business objectives. Under the direction of a Team Leader or Mentor: develop and implement effective strategies for FDA promotional submissions; manage the development of correspondence with FDA and the interpretation of FDA advisory comments. Conduct regulatory risk analysis and identify regulatory issues. Maintain current awareness and understanding of FDA advisory correspondence, evolving FDA regulations and guidance documents, FDA enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Communicate (written and verbal) basic regulatory positions. Contribute to departmental or cross-functional initiatives to ensure effective and efficient promotional review practices.
Requirements
- B.A. or B.S. degree with an emphasis in science, health care or related fields
- Minimum two years’ experience in pharmaceutical/biologics industry or related field, preferably in the regulatory, scientific, medical, legal or marketing disciplines
- Basic understanding of FDA regulations relating to advertising and promotion for prescription products with a steadfast focus on quality & compliance
- Fundamental understanding of the pharmaceutical industry drug development process, including labeling development
- Understanding of the promotional content development and review processes
- Strong verbal and written communication skills
- Attention to detail and ability to manage multiple priorities simultaneously
- Strong interpersonal skills with ability to demonstrate strategic and analytical thinking
- Action oriented with strong cross-functional collaboration skills
- Adverse Event Report
- Biopharmaceuticals
- Compliance Investigations
- Cross-Functional Collaboration
- Detail-Oriented
- Drug Development
- FDA Regulations
- Labeling Compliance
- Negotiation
- Oral Communications
- Pharmaceutical Development
- Policy Implementation
- Records Retention Management
- Regulatory Communications
- Regulatory Issues
- Regulatory Risk
- Regulatory Strategy Development
- Regulatory Submissions
- Risk Analysis
- Technical Writing
Nice To Haves
- Master’s, PhD or PharmD degree with an emphasis in science, health care or related fields
Responsibilities
- Review and approval of US promotional materials
- Develop and implement effective strategies for FDA promotional submissions
- Manage the development of correspondence with FDA and the interpretation of FDA advisory comments
- Conduct regulatory risk analysis and identify regulatory issues
- Maintain current awareness and understanding of FDA advisory correspondence, evolving FDA regulations and guidance documents, FDA enforcement letters and policy issues affecting the pharmaceutical/biologics industry
- Communicate basic regulatory positions (written and verbal)
- Contribute to departmental or cross-functional initiatives to ensure effective and efficient promotional review practices
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Senior
