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Principal Regulatory Affairs Specialist
1 month ago
Job Description: Principal Regulatory Affairs Specialist
Position Objectives: Lead product strategy, regulatory compliance, market expansion, and change management for consumer products (Rx/OTC, Nutritional, Cosmetics).
Responsibilities:
- Interpret and apply regulatory policies and guidelines.
- Innovate and promote successful regulatory submissions.
- Review scientific information and ensure data supports conclusions.
- React to regulatory changes and recommend strategies to minimise risk.
- Influence regulatory stakeholders and shape the regulatory environment.
- Lead projects and influence cross-functional team members.
- Work with national opinion leaders and advisory boards.
- Provide regulatory guidance to project teams.
- Act as the primary contact with Health Authorities.
- Review materials and advise on regulatory compliance.
- Maintain regulatory databases for product accuracy.
- Mentor and coach team members.
- Provide technical expertise and participate in industry forums.
Qualifications:
- Bachelor’s degree preferred.
- 8+ years in Regulatory Affairs within the consumer product sector.
- Strong understanding of regulatory processes and systems.
- Excellent analytical, organizational, and communication skills.
- Ability to influence stakeholders and handle multiple tasks.
- Detail-oriented with experience in FDA regulations and CFR.
- Ability to independently conduct activities and react decisively in unexpected situations.
Join us to drive regulatory excellence and ensure compliance for innovative consumer products Apply now