Senior Regulatory Affairs Specialist
1 month ago
About CK Group
We are recruiting for a highly skilled Regulatory Life Cycle Management Scientist to join our client, a global Consumer Healthcare company based in Reading, on a contract basis for 12 months.
The Role
This is an excellent opportunity for an experienced professional to take ownership of coordinating regulatory life cycle management activities across multiple countries within and outside Europe. You will work closely with local regulatory affairs teams to ensure compliance with health authority requests, manage global master dossiers, and maintain accurate records in Veeva Quality Tracking systems.
Key Responsibilities:
- Coordinate regulatory life cycle management activities, including variations, renewals, and answering health authority requests.
- Maintain global master dossiers, compile, review, and provide dossiers for local registration and compliance.
- Ensure regulatory assessments are conducted for change controls in Veeva Quality Tracking systems.
- Maintain and update the Veeva Regulatory Information Management system for all activities under role responsibility.
- Provide strategic input into regional product labelling and approval to enable commercial activation of product launches.
Your Background
To be successful in this role, you will need:
- A degree in pharmacy, engineering, chemistry or a similar field, ideally at Master's level.
- Regulatory affairs experience in OTC medicinal products and lifecycle management across EU or wider markets.
- Experience in dossier maintenance and product change management, as well as working with complex regulatory databases.
- Excellent attention to detail, good communication, and presentation skills.
What We Offer
This is a fantastic opportunity to work with a leading consumer healthcare company, with a competitive salary of £55,000 - £65,000 per annum (dependent on experience) and a comprehensive benefits package.
Please note that it is essential to have entitlement to work in the UK and to quote job reference 106651 in all correspondence.
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