As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Level: Mid
- Travel: Yes
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Success Profile
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
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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