Senior Regulatory Affairs Manager - CMC (various locations)
United Kingdom, Remote Job ID R0000027731 Category Regulatory / Consulting Date Posted 09/19/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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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