BPL-JOB DESCRIPTION

Post Details
Job Title: / Head ofRegulatory Affairs (HRA)
Generic Job Title: / Head of Regulatory Affairs
Band: / 8C
Department/Directorate: / Regulatory Affairs /Technical
Accountable to: / Technical Director
Main Job Purpose
The prime purpose of the job is to head up the management of the Regulatory team to ensure that all of BPL’s therapeutic products obtain the necessary authorisations to allow manufacture and achieve marketing of the products within the UK, and overseas territories; as identified by the Executive and the Marketing Department. The purpose of obtaining these authorisations is to optimise BPL’s position within the market place.
The HRA role contributes to assurance of compliance through provision of information and advice to BPL during implementation and changes to the licensed processes.
Organisation Structure
Key Duties and Responsibilities
The preparation and timely submission of all regulatory applications: product licences, clinical trial and clinical trial exemption certificates, manufacturer’s ordinary and specials licences and wholesale dealers certificates for the UK, EC and other overseas Regulatory Authorities.
This will be achieved by directing and managing the following activities :
  • the collection, collation and review of scientific and technical data on all aspects of BPL’s product development and manufacturing,
  • organising and establishing the required product packaging for Regulatory compliance and technical compliance with BPL,
  • directing the BPL policy on style and approach to the dossier format (paper and electronic) to be compliant with Regulatory requirements and to ensure easy review to achieve timely and advantageous approvals,
  • guiding and carrying out the preparation and scripting of texts in a form consistent with current scientific guidelines on regulatory submissions,
  • providing strategic regulatory advice and scientific assistance to other members of BPL staff involved in product development and the scripting of texts, in particular guidance on the requirements of various regulatory authorities with respect to specific aspects,
  • managing the scheduling, co-ordination and general project control of contributions to each submissions, producing a high standard of final text, for submission by an agreed date,
  • ensuring the verification of the accuracy of the prepared texts,
  • liaising with relevant Regulatory Authorities and Overseas Agents at all stages to achieve licence grant within agreed and expected time frames
  • Analysing and resolving all problems arising from the planning of the regulatory submission, text preparation and regulatory assessment.
Take responsibility for, and manage, the maintenance of all regulatory authorisations held by BPL.
This will be achieved by:
  • designing and maintaining a database of all regulatory submissions including correspondence subsequent to initial submission,
  • managing the review for regulatory approval of all processes and associated changes, raw material changes and packaging copy changes,
  • managing the review of application for licence renewals,
  • managing and providing advice on the scope for, and limitations to, changes in 2.2.2 above in the regulatory context,
  • managing the implementation of any change agreed with or imposed by any Regulatory Authority relevant to BPL’s activities,
  • Analysing and resolving any issues relating to licence updates resulting from interaction within BPL and the Regulatory Authorities.
  • managing the implementation and correct use of the BPL eCTD software and publishing of electronic Regulatory submissions in eCTD ICH format. Also the HRA manages and overseas the provision of paper copy and non eCTD CTD electronic submissions depending on the requirements of individual Agencies.
Provide advice on regulatory strategy and regulatory requirements.
This will be achieved by:
  • ensuring the provision of regulatory advice bulletins and advice manuals based on the dissemination of Regulatory requirements.
  • maintaining awareness, both personal and site-wide in BPL, of changing regulatory requirements and their implications to BPL,
  • maintaining a database of relevant regulatory publications and circulating copies to appropriate BPL staff.
  • attendance and occasional presentations to international and national fora and to national competent authorities across the world.
Review changes to, or updates of, packaging and promotional material to ensure compliance with product licences, medicines act regulations and professional codes of conduct.
Manage the copy approval systems for packaging material under review.
The HRA manages the unit’s budget and assigns resources and priorities to maximise the team’s efficiency and contribution in terms of its Regulatory function within BPL.
Manage the BPL Regulatory Unit to direct staff schedules and priorities and control expenditure within agreed budgets.
Principle Resources Controlled
Four to five members of staff
Plan and control budget of approximately £1,500,000
13 major line products registered in the UK with a mix of these registered or being registered in over 50 countries world-wide.
Three manufacturing licences and two wholesale dealers licences.
New product registrations through clinical trials and licensing
Orphan drug products in both the EU and USA.
Centrally approved EU Plasma Master File.
Project manage and organise resources to be able to deal with the variety of registration commitments being worked on and planned for.
Schedule provision of components of a registration dossier and organise project groups to facilitate provision of technically appropriate scripts within agreed time-frames.
Plan the administration needs of the RA unit to function in compliance with good practice and accountability. Direct the organisation of the filing and control systems to maintain effective management of the RA unit.
Plan the strategy for the most efficient route to obtain market authorisation to maximise BPL’s market share.
Acceptance and Review
Accepted
Manager.(signed) ...... Date......
Manager (printed) ………………………………….
Jobholder (signed) ...... Date......
Jobholder (printed) …………………………………

H:\D05\DATA\PERS\Recruitment\Job Descriptions\Technical\Regulatory Affairs\Head of Regulatory Affairs - JD.doc