Post Details
Title of Post: / Head of Regulatory Affairs
Grade: / Personal
Department/Directorate: / Regulatory Affairs
Accountable to: / Quality Director
Responsible for: / Regulatory Affairs Department
Liaises with: / All departments, regulatory bodies and authorities
Main Job Purpose
The prime purpose of the job is manage the Regulatory team to ensure that all of BPL’s therapeutic products obtain and maintain 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 global market place.
The HRA role is keep up to date of ever-changing national and international legislation, related to medicinal products, to ensure that BPL is in a position to distribute its products in a compliant manner through the provision of information and advice to BPL during implementation and changes to the licensing processes
Organisational Structure
Key Duties and Responsibilities
The preparation and timely submission of all regulatory applications: product licences, clinical trial applications (CTA), Investigation of New Drug Applications (IND), orphan drug submissions, manufacturer’s ordinary and specialist licences and wholesale dealers certificates for the UK, EU, FDA 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 international 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 submission, 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 electronic submissions depending on the requirements of individual Agencies.
Provide advice on regulatory strategy and regulatory requirements.
This will be achieved by:
  • using experience and knowledge to interpret official regulation and guidance to develop BPL specific strategy policies for license strategy at home and overseas
  • arranging and overseeing scientific meetings with the regulators in order to discuss and agree strategy for product development and license submissions
  • 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
Manage the departmental budget of over £1m
Acceptance and Review
Accepted
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