We have an exciting opportunity for a Registration Officer to join a leading Global Healthcare company based in the Hertfordshire area.
As the Registration Officer you will be responsible for management of regulatory activities in order to obtain and maintain marketing authorisations for products in the UK, as well as any other registration or special project activities as required by line management in accordance with departmental objectives and regional and global regulatory strategy.
This is a hybrid role that will require up to 2 days per week on site in Hertfordshire.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Registration Officer will be varied however the key duties and responsibilities are as follows:
1.
As Registration Officer you will maintain marketing authorisations for an assigned product portfolio, ensuring on-time submissions for all safety related changes for assigned projects.
2.
You will devise regulatory strategies (including advising of the regulatory requirements) for post-approval submissions with support from Line Manager, and ensuring suitable post-approval submissions are prepared and dispatched on-time according to agreed company procedures and objectives.
3.
Maintain product information and artwork for designated UK marketed products within the correct system, to reflect current registered versions, and create and maintain Abbreviated Prescribing Information, as requested, to support Marketing team activities.
4.
Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure regulatory Compliance are maintained.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Registration Officer we are looking to identify the following on your profile and past history:
1.
Relevant degree in a Life Sciences subject or related area (e.g.
Biology / Biomedical Science)
2.
A working knowledge and demonstrable experience in Regulatory Affairs
3.
Proven industry experience in managing large volume and fast paced product portfolios, and flexible approach to enable prioritisation in line with company requirements
Key Words: Registration Officer | Regulatory Affairs | Healthcare | Pharmaceutical | SmPC | PIL | SOPs | Pharmacovigilance | Post-Approval Submissions
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.