Biologics Regulatory Affairs Associate Director / Director

05 June 2018





Reports to: Technical Director

Based at: Harlow UK

Job Description

The Biologics Regulatory Affairs Professional provides development stage advice to internal staff and to clients for a broad range of biologics and/or Cell and Gene Therapy programmes. They will possess a strong understanding of existing and leading-edge technologies, and is able to speak knowledgeably about client programmes. They will provide the following expertise based services:

  • To be a client lead
  • Expert regulatory documentation author (IMPDs/INDs)
  • Provide leadership in scientific advice meetings at national agencies and EMA
  • Lead EMA procedures including orphan applications, PIPs and MAAs
  • Point of contact for agency interaction
  • Provide expert EU regulatory strategy
  • Project management/lead responsibilities
  • Client facing with strong communication skills, willing to travel
  • To assist the senior management team by providing leadership support to a team of internal consultants and their clients
  • To 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:

  • Writing product development plans and providing gap analysis
  • IMPD/IND writing
  • Technical CMC support
  • Preparing orphan applications, PIPs and PRIME submissions
  • Assisting with scientific advice procedures
  • Clinical Trial Application submissions
  • GMO applications
  • Ethics submissions
  • Assistance in preparing and submitting variations and Marketing Authorisation Applications through the various Regulatory Authority procedures
  • Acting as an overflow Regulatory Department

Key Responsibilities and Duties of the Role

Provide world-class advice across a range of biologics and/or cell and gene therapy product types

  • Advise global clinical development teams in the requirements for EU based programmes, and to integrate with other regional experts.
  • Provide development related strategy for a broad range of programmes
  • Provide Biologics and/or ATMP advice and dossier support for US based programmes
  • Lead EMA procedures including orphan applications, PIPs and MAAs
  • Provide expert EU regulatory strategy
  • Regulatory lead and point of contact for national agency and EMA interactions
  • Provide direct line management and matrix team based leadership where needed
  • High level of client focus and accountability
  • Assist with Business Development activities by taking part in new prospective client-lead discussions

Professional Experience

Essentials

  • Degree or higher in Chemistry, Biochemistry, Biology or related scientific disciplines
  • 5+ years broad & deep European regulatory affairs experience with Biologics and/or ATMPs
  • Biologics/ATMP regulatory expert with demonstrable experience in liaising and negotiating with regulatory authorities
  • Demonstrable experience in orphan applications and PIPs
  • Strong understanding of the regulatory environment including guidelines
  • Ability to lead team members in a matrix management environment
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Excellent computer skills
  • Collaborative approach and able to work effectively with matrix based teams involving internal staff, client teams that include independent consultants
  • Confident speaker about regulatory challenges in the clinical development of biological and next generation technologies, and approaches to finding solutions.

Preferences:

  • >10 years of relevant experience in biologics development
  • >7 years of experience in regulatory affairs based activities and regulatory authority interactions
  • Exposure to MAA dossier writing and submission procedures
  • US FDA facing experience

Personal Attributes

  • Innovative and pragmatic problem solver
  • Attention to detail
  • Strong communicator with the ability to influence
  • Completer-finisher able to provide decisive leadership in a project team setting
  • Ability to provide a flexible, proactive and dedicated approach whilst dealing with clients with different working styles and cultures.
  • Strong client focus