Biologics Regulatory Affairs Vacancies


1. Senior Biologics Regulatory Professional, Diamond BioPharm Ltd

As part of our continuing growth we have a vacancy available for a senior regulatory professional with 5+ years biologics experience. Title dependent on experience.

Key Responsibilities and duties of the role:

  • A lead client facing consultant
  • Leads regulatory projects for clients with clinical stage biologics programmes
  • Expert regulatory documentation author with CMC experience preferred
  • Experience in IMPD or IND writing
  • Experience in MAA/BLA desirable
  • Experience preparing PIPs, Orphan Applications and Scientific Advice Meetings
  • Point of contact with regulatory authorities on behalf of clients

Professional Experience

Essentials:

  • Minimum of 5+ years biologics experience in a regulatory capacity
  • Biologics regulatory expert with demonstrable experience in liaising and negotiating with regulatory authorities
  • Experience in regulatory activities for biologics including monoclonal antibodies
  • 2:1 (or above) Degree in Scientific discipline
  • Strong understanding of the regulatory environment including guidelines
  • Proven ability to engage with potential clients across a range of cultures, backgrounds and disciplines
  • Excellent computer skills

Personality attributes

  • Ability to work on their own and to be an influential leader of a team
  • Self-motivated and pro-active with excellent communication skills
  • Well organised and good planning abilities
  • Good eye for detail
  • Multi-tasking

Please apply by sending your CV and covering letter to email

 

2. Biologics Regulatory Professional, Diamond BioPharm Ltd

As part of our continuing growth we have a vacancy available for regulatory professionals with 2 to 4 years biologics experience.

Key Responsibilities and duties of the role:

  • Client facing consultant
  • Leads regulatory projects for clients with clinical stage biologics programmes
  • Expert regulatory documentation author with CMC experience preferred
  • Experience in IMPD or IND writing
  • Experience in MAA/BLA desirable
  • Experience preparing PIPs, Orphan Applications and Scientific Advice Meetings is desirable

Professional Experience

Essentials:

  • Minimum of 3+ years biologics experience in a regulatory capacity
  • Experience in regulatory activities for biologics including monoclonal antibodies
  • 2:1 (or above) Degree in Scientific discipline
  • Strong understanding of the regulatory environment including guidelines
  • Proven ability to engage with potential clients across a range of cultures, backgrounds and disciplines
  • Excellent computer skills

Personality attributes

  • Ability to work on their own and as part of a team
  • Self-motivated and pro-active with excellent communication skills
  • Well organised and good planning abilities
  • Good eye for detail
  • Multi-tasking

Please apply by sending your CV and covering letter to email