Regulatory Affairs Lead

Wentworth Pharmaceutical
11 Jan 2018
17 Feb 2018
Contract Type
Full Time
This position is with a Global biotech as a Senior RA Manager working at a strategic level on development within regulatory affairs. Due to expansion and new projects, this opportunity is available on a permanent basis with the company.

Location: Office based in the London or Cambridge

Type of contract: Permanent

Hours per week: Full time

Start date: Q1 2018

Key responsibilities

- Planning and managing regulatory submissions (e.g. clinical trial and marketing applications) for products within the company's portfolio
- Providing regulatory direction on regional regulatory mechanisms to optimize product development
- Obtaining and maintaining CTA's and MAA's including Response to Questions
- Ensuring regulatory product compliance for all products

Skills, expertise and contribution

- Leading development activities

- Scientific Advice

- Registration of initial MAA's

- Large molecules

- Global markets

Minimum Qualifications

- Degree (within Life Sciences), often with higher degree/qualification

- Experience as an RA manager or similar

- Proven ability to manage multiple tasks with attention to detail.

- Relevant experience in (regulatory) development within the pharmaceutical, biopharmaceutical or CRO industry

Strong remuneration package.

For more information please apply and a consultant will be in contact asap.