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Senior Regulatory Affairs Officer
4 weeks ago
Our client, based in Dartford, were established in 2011. UK owned they are now expanding and are looking to recruit a Senior Regulatory Affairs Officer.
Qualifications and Experience (as applicable):
- Educated to degree level in science or equivalent experience.
- Minimum 5- 7 years of experience in the Regulatory Affairs regulatory experience with new product introduction within the pharmaceutical industry covering both UK National and European regulations
- Strong communication and project management skills
- Proficiency in the use of MS Office suite (Excel, PowerPoint)
- Ability to take initiative and work with different departments as a team player within the organisation
- Strong problem-solving and analytical skills. Facilitation and Leadership skills
Job Description:
- Manage life cycle/ post-authorisation changes for UK relating to CMC, clinical, safety and product Information changes.
- Writing, Compiling and Publishing Dossiers for UK National & EU Submissions.
- Knowledge of requirements of Minor and Major complex Variations.
- Compiling information and data for amendments to marketing authorisations. Submitting the variations to marketing authorisations and working with the MHRA and other regulatory bodies to resolve any RFI s arising during review of these variations.
- Sound knowledge on requirements of MA Transfer in EU territories, which includes requirements of notarisations and translations.
- Ensure that CMC practices are carried out in accordance with the requirements of regulatory bodies.
- Developing and writing clear explanations (Bio-waiver Justifications, Manufacturing Justifications etc.,) for new product licences and Variations.
- Sound knowledge on requirements in development of product information for UK and EU.
- Develop and approve artwork components and patient information (SPC, PIL, cartons and labelling) and associated mock-ups.
- Prepare Artwork Submissions that include P1 Applications, Article 61 (3) Notifications
- Liaise with the External Pharmacovigilance consultants for submission of Safety variations and PSUSA Variations.
- Working with specialist computer software and resources; (Eg: ectd).
- Experience in uploading the product information to databases like EMC.
- Experience in submissions using MHRA and CESP Portals.
Monday to Friday. Full Time
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