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Senior Regulatory Affairs Manager - CMC (various locations)

Remote:

Full Remote

Contract:

Full time

Experience:

Expert & Leadership (>10 years)

Work from:

United Kingdom

Offer summary

Qualifications:

10+ years of experience in regulatory affairs, Extensive knowledge of CMC writing, In-depth understanding of EU guidelines, Excellent project management skills, Strong communication and client management skills.

Key responsabilities:

Write CMC sections for submissions
Develop and implement variation strategies
Coordinate CMC activities across projects
Liaise with global affiliates and sites
Identify business opportunities and prepare proposals

Lifelancer Information Technology & Services Startup https://lifelancer.com/

11 - 50 Employees

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Job description

We are looking for aSenior Regulatory Affairs Manager/Consultantwith 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

Preferred Qualifications:

Experience with regulatory agencies (e.g., FDA, MHRA)
Industry-recognized certifications or advanced degrees
Publication history or experience presenting at industry conferences

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

https://lifelancer.com/jobs/view/6becd14d25e8333b398d3ccbf0425c92