Regulatory Affairs Director
4 days ago
We are seeking a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global pharmaceutical environment.
This is a client-dedicated project without people management responsibility. The role can be home or office based in various European locations.
Key Responsibilities:
- Write CMC sections (23S, 23P, 32S, 32P) and scientific rationales for regulatory submissions and responses
- Develop and implement variations strategies based on EU guidelines
- Coordinate CMC activities across multiple projects
- Liaise with global affiliates and manufacturing sites
- Provide project leadership and management
- Ensure client satisfaction and project quality
- Identify new business opportunities and contribute to proposal preparation
Required Qualifications:
- 10+ years of experience in regulatory affairs
- Extensive knowledge of CMC writing and variations strategy
- In-depth understanding of EU guidelines (Variation, ICH, EMA)
- Excellent project management and organizational skills
- Strong communication abilities and client management experience
- Ability to work independently and as part of a team
- Proficiency in English; additional languages are a plus
Salary Estimate: $120,000 - $150,000 per year
Company Overview: Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.
Benefits:
- Competitive salary range
- Ongoing training and professional development opportunities
- A supportive and collaborative work environment
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