Back to searchSenior Regulatory Affairs Officer
Hyper Recruitment Solutions LTD
Posted 12 days ago, valid for 7 days
Ashford, Kent TN26 1NN
£45,000 per annum
Full Time
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Sonic Summary
- We are seeking a Senior Regulatory Affairs Officer for a leading Pharmaceutical company in Kent.
- The role involves managing product life cycles and post-authorisation changes, focusing on CMC, clinical, safety, and product information modifications.
- Candidates should have a degree in science or equivalent experience, along with proven experience in Regulatory Affairs within the Pharmaceutical industry.
- Strong communication and project management skills are essential, as well as proficiency in MS Office and regulatory submission portals.
- The salary for this position is competitive, and candidates should have a minimum of 3-5 years of relevant experience.
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:
1. Oversee dossier compilation and submission for UK and EU markets.
2. Liaise with regulatory bodies and manage communication regarding variations.
3. Develop product information and approve artwork for regulatory compliance.
4. 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:
1. Educated to degree level in science or equivalent experience.
2. Proven experience in Regulatory Affairs within the Pharmaceutical industry.
3. Strong communication and project management skills.
4. 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 | Artwork | 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.
