Regulatory Affairs Manager
Location: United KingdomSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Cambridgeshire United Kingdom.
- Identify and communicate the relevant regulatory requirements that apply to either new or modified products
- Ensure compliance of all technical files
- Compile and adapt the necessary product documentation to fulfil requirements from different jurisdictions
- Address regulatory requests from customers
- Cooperate with distributors and subsidiaries on product registration
- Liaise with the relevant regulatory bodies and competent authorities
- Raise awareness and train staff in regulatory issues
- Monitor regulatory activities (regulations, standards, guidelines)
- Implement post-marketing surveillance activities
- Confirmed experience (6-10y) in a similar position in the field of Pharmaceuticals or Biotech
- Any other languages would be an asset
- Excellent communicator, rigorous and structured
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
The Company
For one of our Pharmaceutical clients in the Cambridge area we are looking for a Regulatory Affairs ManagerRole Description
Regulatory Affairs ManagerResponsibilities
- Ensure the application of regulatory requirements in all processes, in cooperation with the Quality System Manager- Identify and communicate the relevant regulatory requirements that apply to either new or modified products
- Ensure compliance of all technical files
- Compile and adapt the necessary product documentation to fulfil requirements from different jurisdictions
- Address regulatory requests from customers
- Cooperate with distributors and subsidiaries on product registration
- Liaise with the relevant regulatory bodies and competent authorities
- Raise awareness and train staff in regulatory issues
- Monitor regulatory activities (regulations, standards, guidelines)
- Implement post-marketing surveillance activities
Requirements
- University degree or equivalent- Confirmed experience (6-10y) in a similar position in the field of Pharmaceuticals or Biotech
- Any other languages would be an asset
- Excellent communicator, rigorous and structured
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
