Regulatory Affairs Manager / Senior Manager

25 June 2018





Reports to: Head of Regulatory Affairs

Based at: Harlow UK

Job Description

The Regulatory Affairs Manager / Senior Manager provides leadership in outsourced procedural regulatory affairs services and will be a client lead responsible for line reports. They will provide leadership and execute the following:

  • Line management duties coordinating the duties of allocated members of staff
  • Assist in the assignment of workload priorities
  • Will be a point of contact for clients and with regulatory authorities
  • Will lead National, Centralised and International Marketing Authorisation Applications
  • Provide support to due diligence, gap analysis, regulatory strategy and scientific advice
  • Will assist the senior management team by providing leadership support to a team of internal consultants and their clients
  • Will assist the company in providing regulatory knowledge to business development colleagues during bid defence

General Responsibilities and Duties of the Dept

Diamond BioPharm Limited is the Regulatory function within Diamond Pharma Services. The function provides end to end regulatory services and expertise driven product development advice from early stages of development through to post market support. Our regulatory division are experts in all aspects of European regulatory affairs providing support to clients in the following areas:

  • Providing outsourced regulatory guidance and procedural operations support
  • Preparation and/or coordination and/or review of documentation or dossiers
  • Regulatory strategy (development, pre-submission or post-approval stages)
  • Providing expert EU Regulatory support

Key Responsibilities and Duties of the Role

  • Write or review all types of variations, simple and complex
  • Review and QC check documents for the Linguistic Review process
  • Review updates to Summary of Product Characteristics and Patient Information Leaflets
  • Review the outcomes of Patient Information Leaflet testing and write or review reports
  • Write or review labelling texts for clients, including checking of mock-ups
  • Co-ordinate licensing and post licensing procedures on behalf of clients, i.e. Clinical Trial Applications, National, Mutual Recognition and Centralised Applications under senior staff guidance
  • Write sections of dossiers for Mutual Recognition/Decentralised procedures and Centralised procedures, and co-coordinating those procedures through to approvals through EU.
  • Write Module 2 and Module 3 documents (as applicable)
  • Write regulatory plans, carry out gap analysis and prepare regulatory strategy reports
  • Write and review SOPs/Processes
  • To provide sound strategic advice to clients in line with current guidance, legislation and experience
  • To communicate effectively with clients
  • Have a detailed knowledge of current legislation associated with the Regulatory requirements.
  • Show awareness and the ability to communicate effectively with both customers and staff
  • Be accountable for line management responsibilities
  • To effectively train and develop staff
  • To actively seek business development opportunities across the organisation
  • To assist in the growth of the team and support the senior management team to upskill junior members of staff

Professional Experience

Essentials

  • 2:1 (or above) graduate in relevant scientific discipline
  • 4-7 years prior regulatory affairs experience
  • Understanding of the regulatory environment
  • In depth knowledge of all application types and a variety of therapeutic areas
  • Understanding of Mutual Recognition, Decentralised and Centralised procedures
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Good computer skills
  • Ability to analyse issues and propose solutions

Personal Attributes

  • Confident/Enthusiastic/Outgoing
  • Ability to work on their own or as part of a team
  • Self-motivated with excellent communication skills
  • Well organized and good planning abilities
  • Good eye for detail
  • Multi-tasking