CMC Regulatory Associate

Recruiter
Anonymous
Location
Lancashire
Salary
30000.00 - 33000.00 GBP Annual + GBP30000 - GBP33000/annum
Posted
16 Jun 2017
Closes
24 Jun 2017
Function
Consultant
Contract Type
Permanent
Hours
Full Time
Austin Fraser are supporting a global health care company specialising in advanced life-saving medicines and technologies which support patients who are critically and chronologically ill.

Due to a member of their team going on maternity, they are looking for an enthusiastic and passionate CMC Regulatory Associate to join their team on a full-time and permanent basis.

The Role

- Preparation and/or coordination of regulatory submissions for investigational and commercial products in the EU and International markets; including support to the major MAA submissions

- Responsible for the preparation of high quality chemistry, manufacturing and controls (CMC) documentation to support clinical trials, original MAAs, variations and renewals.

- Work closely with international colleagues to ensure consistency with responses to questions.

- Supporting the team in ensuring licence renewals and national product information is up to date and uploaded accurately on the eCTD.

- Co-ordinate the preparation of responses to CMC questions from regulatory authorities.

Requirements:

- Scientific degree coupled with CMC experience

- Experience in the preparation and maintenance of CMC components of regulatory submissions.

- General understanding of CMC regulatory requirements and quality guidelines, including ICH and regional requirements.

-Excellent organisation skills and ability to work on many projects with tight time lines.

- Excellent verbal and written communication skills and interpersonal skills

If you are interested in working for a global company and have the ability to take ownership of projects and work alongside a team with patient care at the forefront of your work decisions, please apply directly and I will be in touch