We are currently looking for a Regulatory Affairs Officer to join a leading Pharmaceutical company based in the West Sussex area.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:
1. Make sure all regulatory submissions for medicinal products for European and Non-European countries are in line the local requirements and regulations.
2. Prepare quality CMC documentation for regulatory submissions, for example; MAAs, responses of deficiencies, variations and ICH requirements.
3. Provide different teams internally regulatory guidance and advice. This will include training more junior team members.
4. Comply with all legislative requirements, good manufacturing practices, quality management systems and site regulations.
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 scientific degree.
2. Proven industry experience in a regulatory pharmaceutical field.
3. A working knowledge and practical experience with current CMC regulatory requirements.
Key Words: RA, Regulatory Affairs, Pharma, GMP, CMC, ICH
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.