Are you and experienced Regulatory Affairs Officer looking for your next move within the pharmaceutical sector?
Or are you an experienced Clinical Trials professional looking to make a lateral move into Regulatory Affairs?
We are currently looking for a Senior Regulatory Affairs Officer to join a leading pharmaceutical company based in the Hertfordshire area.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:
1. Make proposals for product licensing strategies for new products and new markets.
2. Independently manage the regulatory aspects and licensing of Orphan Drugs within the US, EU and/or Intercontinental countries.
3. Provide strategic and operational input to obtain new Marketing Authorisations in the US, European Union (EU) or Intercontinental markets for designated products and manage the product life cycle.
4. Independently, maintain existing licences (commitments, variations, renewals).
5. Independently plan for, communicate directly with the relevant departments to obtain and or generate appropriate documentation necessary to satisfy health authority requirements in the relevant countries.
6. Independently make source documentation available and supervise the generation of regulatory dossiers in eCTD format.
7. Prepare and submit any type of application (Clinical Trial Application, Marketing Authorization Application, variation application, Orphan Drug application, renewal application)
8. Communicate directly with the MHRA (country of origin) and other health authorities seeking advice, guidance or clarification of legal issues or submission processes. Active participation on meetings with FDA and EMA together with superior.
9. Actively maintain RA data bases (RIM/ IDMP), documentation and procedures to ensure regulatory compliance of products released to market.
10. Continuously identify and make proposals for minor and major improvements related to work place, processes and/or systems
To be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in Life Sciences and/or MSc Reg Affairs degree from TOPRA. You will also have records of attendance at relevant Regulatory Affairs conferences and training.
2. Track record of experience in a Regulatory Affairs function involved with world-wide licencing activities. Experience could be gained within pharmaceutical or biopharmaceutical clinical setting.
3. Basic knowledge of ICH and solid knowledge of all aspects of an ICH CTD structured dossier. Solid experience with EU requirements (CEN, DCP, MRP, National) from drug development to final approval and product launch support. Solid experience of managing and executing post approval changes in EU and US. Experience with the Intercontinental Region is a plus.
4. Experience of managing requests from FDA, EMA, national competent authorities and full understanding of the regional procedural time lines. Experience of managing requests from FDA, EMA, national competent authorities and full understanding of the regional procedural time lines.
Key Words: Regulatory Affairs | clinical trials | Pharmaceutical | biopharmaceutical
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.