We are currently looking for a Senior Regulatory Affairs Officer to join a leading Pharmaceutical company based in the Kent area. As the Regulatory Affairs Officer, you will play a pivotal role in managing the life cycle and post-authorisation changes for products within the UK, focusing on CMC, clinical, safety, and product information modifications.
Your expertise will be instrumental in writing, compiling, and publishing dossiers for UK National & EU submissions, ensuring compliance with regulatory requirements.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:
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Oversee dossier compilation and submission for UK and EU markets.
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Liaise with regulatory bodies and manage communication regarding variations.
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Develop product information and approve artwork for regulatory compliance.
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Ensure that CMC practices align with regulatory standards, developing clear justifications for new product licenses and variations.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Regulatory Affairs Officer, we are looking to identify the following on your profile and past history:
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Educated to degree level in science or equivalent experience.
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Proven experience in Regulatory Affairs within the Pharmaceutical industry.
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Strong communication and project management skills.
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Proficiency in MS Office suite and regulatory submission portals.
Key Words: Regulatory Affairs Officer | Pharmaceutical | Life Cycle Management | CMC | Clinical | Safety | Product Information | Dossier | Submission | Variations | MA Transfer | eCTD | EMC | MHRA | CESP | Pharmacovigilance |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications for any applicant who fulfils the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves