Principal Registration Officer

We have a fantastic new opportunity for a Principal Registration Officer to join a leading Global Healthcare organisation based in the Hertfordshire area. As the Principal Registration Officer you will be responsible for obtaining and maintaining authorisations for designated EU and non-EU territories, managing and coordinating the DCP / MRP process and ensuring systems are maintained in accordance with current SOPs and regulatory requirements.
This position is hybrid with the expectation of being on site in Hertforshire 1 day per week.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Principal Registration Officer will be varied however the key duties and responsibilities are as follows:
1. Obtain and maintain generic and branded marketing authorisations for designated EU and non-EU territories to ensure on-time launches, continued supply and the compliance of all products.
2. Manage and coordinate the DCP / MRP process, including leading launch meetings, estimating product approval times, liaising directly with agencies as SMEt. Also advise Senior management of the status and progress of assigned projects to meet departmental and regional objectives and timelines.
3. Ensure databases and systems are maintained in accordance with current SOPs to fulfil regulatory obligations, whilst maintaining an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities).
4. Provide day-to-day support for junior team members as directed by the Regulatory Manager, reviewing data intended for submission and provide advice on deficiencies and issues, and in the preparation of regulatory strategies for new marketing authorisation applications / post-approval submission
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Principal Registration Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences subject
2. Extensive and proven industry experience working with the full lifecycle of existing or new product registrations, including strategy/planning, registrations, monitoring, post marketing approvals, through to launching in accordance with EU regulations.
3. Up do date working knowledge and extensive practical experience with EU regulatory affairs (SME - Subject Matter Expert).
4. Demonstrated in-depth understanding of DCP / MRP processes, and able to give examples of estimating approval times and technical questions around variations and submissions.
Key Words: Registration Officer | Regulatory Affairs | RA | DCP | MRP | Post Marketing Approvals | EU Regulatory Affairs | Healthcare | Pharmaceutical
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.