Regulatory Affairs Director

Recruiter
Umbilical Ltd
Location
London (Greater)
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
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