Regulatory Affairs Manager
Posted on Jan 17, 2019 by Anonymous
We are recruiting for a Regulatory Affairs Manager for a pharmaceutical company based in Hemel Hempstead.
This is an office-based role, and the ideal candidate will need to be based in our Hemel Hempstead offices 5 days a week. Working hours are Monday - Friday, 9am - 5.30pm with 1 hour for lunch.
Our clients business is a pioneering niche pharmaceutical company currently undergoing rapid expansion. There are many opportunities for career development in this fast-growing company and the company place great emphasis on developing their staff, and strongly believe in: an open, empowered friendly team culture.
This is a fun, young, dynamic company with a small but rapidly growing team. The Regulatory Affairs Manager role is an exciting opportunity, where the right candidate will be working alongside the Senior Vice President on a daily basis, in a supportive environment where you can make a real impact on the company.
This is a great role with some fantastic benefits for the successful candidate including
· 31 days holiday including statutory holidays, plus birthday
· Health insurance
· Company mobile and laptop
· Contributory pension scheme
The ideal candidate will have a Bachelors degree equivalent or higher qualification within life science, a strong knowledge of MHRA regulations, Knowledge of DCP/National and lifecycle maintenance, Authoring & preparation of regulatory packages and documents for submissions and Direct, hands-on experience of MA transfers. You will also have experience of Reviewing/annotating and approving artworks and labelling and working with regulatory agencies to clarify and resolve regulatory matters.
You will have the ability to project manage and prioritise workload with attention to detail and a positive can-do attitude and be proficient in Excel and Word.
In addition to this the following would be advantageous.
· Change Control, Corrective and Preventive Actions (CAPA) & Deviation procedures.
· Knowledge of EU, Asia and MENA regulations and post approval procedures
· Conducting gap analysis and review of dossiers
· Implementing falsified medicines directive
· Creating and authoring SOPs
· Consolidation of dossiers into eCTD
Responsibilities will involve:
· Working alongside regulatory colleagues to transfer over 60 MAs worldwide back to the company from the current MA holder.
· Planning, preparation and submission of MA applications, post approval, variations, renewals, post marketing commitment submissions and other ad hoc activities in support of maintaining MAs in the EU, MENA, Africa, Asia and the UK.
· Working alongside the commercial department to determine the viability of entering new markets, and the regulatory requirements, timelines and conditions in these markets.
· Reviewing and submitting artwork and labelling changes, including management of third-party artwork house.
· Managing external pharmacovigilance and medical information 3rd party agent.
· Building and maintaining effective relationships with external clients/partners alongside partners regulatory teams.
· Managing/supporting a range of changing project demands.
· Gap analysis of regulatory documentation, identification of potential challenges and proposal of solutions.
· Developing and maintaining strong working knowledge of regulatory guidelines.
· Liaising with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
· Responsibility for ensuring that all relevant electronic systems are updated and maintained in alignment with regulatory submissions and commitments.
· Ensuring all processes are carried out according to guidelines and standard operating procedures (SOPs).
Vanta Staffing Limited is acting as an Employment agency in relation to this vacancy
Eclipse Recruitment (Hemel) Limited
Cobham Consulting Ltd
Pertemps Hemel Hempstead
Pertemps Hemel Hempstead