Regulatory Affairs Director

Umbilical Ltd
London (Greater)
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Responsibilities and Duties

General Responsibilities and duties of organisation:

- To write, review & submit clinical trial applications and associated documentation (incl. IMPDs, IBs)
- Strategy & Development of products, from early stage to Post-marketing
- Write and compile MAAs - Modules 1-5 (as applicable)
- To write or review all types of simple & complex variations
- Write and review SOPs/processes
- Write and/or review sections of dossiers for Centralised/Decentralised procedures
- Project Management of all regulatory requirements

Key Responsibilities and duties of role:

- 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

Qualifications and Skills

Professional Experience

- 2:1 (or above) graduate in relevant scientific discipline
- 5+ years broad & deep European regulatory affairs experience
- 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