Location:         Essex

Salary:             Circa £50,000   

Hours:             Monday - Friday

Job Type:         Permanent       

Report to:        Head of Regulatory Affairs          

Holiday:           25 days + bank holidays

Benefits:          Great benefits package 

Summary of Role

Under the guidance of the Head of Regulatory Affairs, the role holder 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. The role will ensure the individuals are motivated to contribute to the effectiveness of the overall team and departmental targets and objectives, and the wider business objectives.

Essential Duties and Responsibilities 

Finance

• Responsible for ensuring team productivity and efficiencies within established departmental budget
• Ensure that submissions made to Health Authorities are made in the most economic ways at the least cost
• Ensure that team members pay correct fees to health authorities for any submissions
• Ensure that any additional data requested by Health Authorities is generated  at minimal cost 

Customer

• Monitor, analyse and report on team performance
• Ensure that submissions made to health authorities adhere to agreed submission dates as agreed with relevant departments
• Liaise with other departments within the company ensuring that data requirements for required submissions are communicated and generated to deliver the change required within the required time
• Work with production, marketing and other appropriate departments ensuring regulatory approvals are communicated and ensuring changes are implemented
• Work with cross functional teams allowing new products to be brought to market in the format that the market requires and  as quickly as possible following regulatory approval
• Liaise with regulatory authorities and experts relating to regulatory submissions

Process

• Effective supervision of administration/ work activities of the team to ensure tasks are being delivered on time and handle any queries in a timely manner
• Co-ordinate and/ or prepare review, submit and subsequently manage applications to European and if required other Regulatory Authorities in a timely manner. This will include:
  • Marketing authorisation applications (MRP, DCP, central or national)
  • Variations and renewal requests for existing authorisations
  • Answers to questions and post registration/ approval submissions
  • Clinical trial applications, ethical committee applications
  • Meeting packages for scientific advice and protocol assistance
  • Preparation of periodic safety update reports
  • Preparation of product labelling texts and leaflets
  • Regulatory strategies and tools for product registration
  • Conversion of MAA dossier to CTD format
  • Procedures and quality policy
  • Artwork/ labelling
• Keep up to date with legislation and regulations and provide regulatory input to internal and external business partners
• Supervise and assist assigned team members
• Manage and participate in cross-functional project teams covering
• Collect, review, organise, assemble and check reports and summaries
• Participate in departmental training programmes 

People

• Responsible for attracting, retaining and motivating team members to achieve effective performance standards
• Participate in the training and development of Regulatory Affairs staff
• Support learning and growth through the training promise
• Participate in the  interviewing, hiring and training of employees
• Conduct the following
  • Target setting and appraising performance
  • Rewarding and disciplining employees
  • Addressing complaints and resolving problems 

Specific Departmental Functions

• Responsible for providing information and data on regulatory and other activities to the Head of Regulatory Affairs
• Responsible for Health and Safety of self and staff
• Maintains good knowledge of relevant governance, SOP’s and ways of working 

Additional Role Requirements: 

• Ability to set targets, monitor and report on efficiencies and productivity
• Provide updates on team performance Efficiently respond to questions from staff and colleagues
• Communicate effectively in both written and oral form
• Effectively present information to staff
• Articulate, methodical, attention to detail, flexible, team worker, energetic, self-motivated, down to earth, entrepreneurial.
• An achiever and good listener  

Education / Professional Memberships

• Pharmacy, Chemistry or life sciences graduate
• Membership of The Organisation of Professionals in Regulatory Affairs (or eligible to be a member) 

Specific Experience Required

• Minimum of 7 years 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
• IT literate
• Understanding of e-ctd

To apply for this vacancy please contact:

Name: Jessica Lyons
Telephone: 0208 364 9911
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Please quote reference number: CT476

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