Senior Regulatory Affairs Manager

3 months ago


Dublin, Ireland Parexel Full time

When our values align, there's no limit to what we can achieve.
 

We are looking for 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

Preferred Qualifications:

Experience with regulatory agencies (e.g., FDA, MHRA)

Industry-recognized certifications or advanced degrees

Publication history or experience presenting at industry conferences



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