KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:
1. Preparation and Submission of Marketing Authorisation Applications to MRP, DCP and National procedures.
2. Preparation and submission of product variations including Safety Variations, CMC Variations , Renewals and artwork and labelling changes.
3. Lead the Regulatory approval process for line extensions and life cycle management activities.
4. Work closely with the Regulatory Affairs Manager to ensure compliance of all regulatory activities and raise Change Controls as appropriate.
To be successful in your application to this exciting opportunity as the Regulatory Affairs Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline with previous Regulatory Affairs experience. Ideally looking for 2 years+ within the Pharmaceutical industry but OTC and Generics will also be considered.
2. Proven industry experience of handling Regulatory Submissions to UK and Ireland authorities, where experience of EU and Global markets would be beneficial.
3. A working knowledge and practical experience with Life cycle maintenance and post marketing authorisation is important where you have dealt with Health Authorities to negotiate and agree positive submissions.
Key Words: Regulatory Affairs | MAA | Post Marketing Authorisation | Life Cycle Management | Variations | Renewals | Submissions | EU | UK | Pharmaceutical | OTC | Genetic | Regulatory Affairs Officer
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil 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.
- Regulatory Affairs
- Post Marketing
- Life Cycle Managment
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