Senior Regulatory Affairs Officer

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