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