We are looking to speak to experienced Regulatory Affairs professionals who are seeking their next challenge. Our client is a dynamic, fast growing business with a entrepreneurial passion and a pipeline to match!
Working in a close knit team of five, the Regulatory Affairs Manager’s role is to take responsibility for and execute various regulatory activities related to EMEA and UK region. This is not a managerial position.
*** You must have experience working within generics ***
Responsibilities include:
- Preparation, submission, and management of variation applications to agreed timelines.
- Manage and submit Renewals and PSURs in line with specified timelines.
- Preparation, submission, and management of approvals of National, Mutual Recognition, Decentralised Procedure applications in the region.
- Preparation and maintenance of the product information (SmPC/PIL).
- Management of all regulatory activities related to the UK and EU markets (including artwork approvals, maintenance of Manufacturer’s / Importer licence (MIA) etc.)
- Record data in relevant regulatory database.
- Maintenance of a regulatory archive (dossiers, documents, electronic media).
- Preparation of regular reports for regulatory and management purposes.
- Support to the various business functions (e.g. portfolio, out licensing, launch management)
- Proactively contribute to the strategic development of the regulatory function as a whole and hence to the successful development of the commercial operations in Europe, Middle East and Africa.
- Ensure development of procedures for compliance purposes
- Manage or guide more junior staff when required.
Qualifications and Role Requirements
- Life Sciences degree or equivalent is essential.
- An in-depth understanding and experience of EU regulatory requirements including marketing authorisation submissions and maintenance activities on a European level.
- Experience working in a UK affiliate is a requirement.
- Experience in other non-EU markets in the region is an advantage.
- Proven success in the timely management of regulatory approval procedures
- Ability to work to deadlines and able to successfully prioritise numerous projects simultaneously.
- Ability to work independently as well as within a team
- Excellent verbal and written communication skills.
- IT skills at an advanced level (Excel and other MS Office tools, various Regulatory Affairs Information Systems such as eCTD publishing tools, databases and tracking systems, CESP, MHRA portal, etc.)
- Ability to work in a multicultural environment.
On offer:
- Competitive salary banding plus Bonus – on target achievement of PMP up to 12%
- 28 Days annual leave plus bank and public holidays
- Life assurance – x4 annual salary
- Private medical insurance – self and spouse
- Pension 7.5% contribution from employer – minimum employee contribution 0.5%
Pro4orm People Ltd is acting as an Employment Agency in relation to this vacancy. Pro4orm People Ltd will only be able to contact successful applicants within 5 working days. We may, however, contact you regarding other potential roles of interest. By applying for this position you will be agreeing to our Terms and Conditions, and Privacy Policy which can be found on our website www.pro4ormpeople.com