We are currently looking for a Regulatory Associate Officer to join a leading Pharmaceutical company based in the Cambridge area. As the Regulatory Associate Officer you will be responsible for supporting the regulatory and quality teams in compiling regulatory documentation.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Associate Officer will be varied however the key duties and responsibilities are as follows:
1. Liaise with health authorities and respond to their questions in accordance with SOPs and current legislation and guidance.
2. As a Regulatory Affairs Associate you will prepare, compile, review and forward regulatory documentation to third parties.
3. Maintain registration documentation and associated electronic databases
4. Establish procedures for maintaining compliance with regulatory standards and participate in inspections by notified bodies as and when required.
To be successful in your application to this exciting opportunity as the Regulatory Associate Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in a science subject including but not limited to Pharmaceutical chemistry, Chemistry, Biochemistry.
2. Proven industry experience in regulatory affairs technical report writing.
3. A working knowledge and practical experience with pharmaceutical guidelines outlined in ICH, Eudralex vol.4, WHO, FDA.
Key Words: Regulatory Affairs | Technical report writing | Health Authorities | pharmaceutical guidelines | Generics | Product licenses | Submissions | Pharmaceutical | Quality | Technical
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.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Georgina Hillier
- Phone: 0203 910 2980
- Reference: J5632476
- Posted: 1st November 2019
- Expires: 29th November 2019