Our client, are market leaders in the manufacture and supply of specialty pharmaceuticals and services for healthcare professionals in the UK and worldwide. They are seeking a Regulatory Affairs Team Leader for their location in Essex.
The Regulatory Affairs Leader is responsible for training, planning, organisation, delegation of work and managing the activities of their team members within the Regulatory Affairs department ensuring that regulatory submissions with the required data are submitted correctly to the concerned authorities to previously agreed timelines.
PRINCIPAL RESPONSIBILITIES include:
Responsible for ensuring team productivity and efficiencies within established departmental budget
Ensuring that submissions made to Health Authorities are made in the most economic ways at the least cost
Ensuring that team members pay correct fees to health authorities for any submissions
Ensuring that any additional data requested by Health Authorities is generated at minimal cost
Monitoring, analysing and reporting on team performance
Ensuring that data requirements for required submissions are communicated and generated to deliver the change required within the required time
Ensuring regulatory approvals are communicated and ensuring changes are implemented
Co-ordinate and / or prepare, review, submit and subsequently manage applications to European and if required other Regulatory Authorities in a timely manner
Supervise and assist assigned team members
Manage and participate in cross-functional project teams covering
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Degree in Pharmacy, Chemistry or Life Science
Membership of The Organisation of Professionals in Regulatory Affairs (or eligible to be a member)
European Regulatory Affairs experience which includes the submission of variations, renewals new licence application submissions using as a minimum decentralised, mutual recognition and national procedures and preparation of PSURs.
Experience in communicating with European Regulatory Authorities
Understanding of e-ctd
PERSONAL SKILLS & ATTRIBUTES:
Good communication and interpersonal skills
Good technical skills
Team working ability
Fforde is acting as a recruitment agency/business.
KEY WORDS: Regulatory Affairs, Drug Development, Drug Safety, Clinical Research, Clinical Trial, Clinical Study, Submission, Degree, Pharmacy, E-Ctd, Chemistry, Life Science, Pharmaceutical, CRO, Essex, UK