As Regulatory Affairs Specialist - CMC you will undertake the life cycle management of a range of drug products and drug substances produced for the a wide range of markets. You will be a member of the Regulatory Affairs team within the CMC department based in the Dublin plant.
The Regulatory Affairs Specialist - CMC at the Dublin site will be responsible for the life cycle management of quality documentation for the company's products. You will perform regulatory assessments of change control areas and also prepare regulatory strategies for variation applications and participate in the preparation of the quality documentation for various submissions as part of a cross-functional team.
- Perform regulatory assessment of change control cases
- Prepare regulatory strategies for variation applications and participate in the preparation of the quality documentation for various submissions.
- Obtain approvals in new markets and support renewal applications.
- Work in RA product teams where you in close cooperation with other Regulatory Affairs colleagues will plan and project-manage CMC related aspects regarding submissions of variations.
- Create and maintain the quality documentation and handle CMC-related issues for the drug products and drug substances.
Qualifications and Skills
- 3 years+ Regulatory Affairs experience within CMC development or life-cycle management of approved products
- Knowledge of regulatory requirements within EU - preferably also in other major markets and countries outside EU
- Clear focus on agreed objectives, even when working with tight deadlines
- Scientific Master degree, bachelor degree or similar work experience
As Regulatory Specialist - CMC you will need to be a strong, enthusiastic communicator with the ability to take ownership, work effectively as part of a team and thrives on working in an international environment.
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To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales