HEAD OF REGULATORY CONTROL - CMC

Date Posted: 5/9/2017 Application Close: 30/11/2017 Location: Arcinova - Alnwick

Description:

The successful applicant will have an in-depth knowledge of small molecule CMC regulatory requirements across the clinical phases and sufficient knowledge of large molecule regulatory submissions to allow their preparation within the team.

The role will include:

The provision of managerial and regulatory leadership for a team of scientists engaged in the preparation of global CMC regulatory submissions
Actively coordinating, producing and reviewing CMC regulatory documentation
Participating in discussions with potential CMC regulatory clients and assisting in the preparation of work proposals in this area
Providing API and drug product related CMC regulatory advice to colleagues and ARCINOVA clients
Providing regulatory advice and documentation to clients planning to attend meetings with regulatory agencies and supporting responses to regulatory questions
Working flexibly to meet business needs
Excellent written and oral communication skills together with good interpersonal and organisational skills are essential

 

To apply please email your letter of application, CV and any relevant supporting documents to enquiries@arcinova.uk FAO of Nikki Edwell, Human Resources.

See this post on  the Arcinova website.