Hobson Prior are currently looking for a Manager Regulatory Affairs CMC to join a brilliant biotech establishment on a contract basis located in Cambridge. Our client is focused on life-threatening diseases and evolving novel remedies for them.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will organise the planning of replies to CMC queries from regulatory bodies.
• To distribute the CMC components for CTAs, marketing applications, variations and renewals, you will collaborate with pharmaceutical development, manufacturing, QA and associates on an external level.
• Keep an up to date consciousness of CMC regulatory needs for applicable locations and commune crucial intelligence to the organisation in a timely fashion.
• To assist regulatory proposals in Europe, which involves the UK, Switzerland, Balkans and Israel, you will organise the planning of high-quality CMC reports.

Requirements:

• Familiarity with regulatory affairs, as well as know-how of regulatory needs, which involves ICH necessities and local needs.
• Able to plan and conclude CMC regulatory reports and handle current upkeep of present product licenses.
• A well-versed individual who is experienced with regulatory documents and proposal management systems.
• Social and communication abilities, both verbally and written.
• An organised individual with the ability to operate on multiple projects simultaneously to meet deadlines.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.