Regulatory Professionals

Regulatory Affairs Manager

Location
Cambridgeshire
Salary
Competitive
Posted
07 Nov 2018
Closes
14 Feb 2019
Ref
JO-1811-419402
Discipline
Regulatory Affairs

Regulatory Affairs Manager

Cambridgeshire or Uxbridge

permanent

Competitive salary with attractive benefit package

Reference:JO-1811-419402


Regulatory Professionals are collaborating with a global bio-pharmaceutical company with a strong pipeline including treatments for cancer and respiratory disease treatments. With an outstanding reputation and rapidly expanding portfolio, this is a great time to get on board and join their team.


job responsibility:
Lead teams in the preparation of EU Marketing Authorisation Applications (Centralised Procedure) for products in development.
preparing and coordinating the regulatory documentation to support Clinical Trial Applications/ amendments, scientific advice procedures and PIP in the EU.
responsible for ensuring product packaging and associated information is updated and maintained in accordance with MAAs in responsible territories including the reviewing of labeling translations.
Reporting directly to the Associate Director in International Regulatory Affairs and will be responsible for preparing Regulatory submissions.

candidate responsibilities:
Degree in biological/life sciences, pharmacy or medicine. An advanced degree is desirable.
Over 5 years of experience working on MAAs
Few years of experience working on CTAs
Must have prior experience with Centralised procedures
Prior experience with PIPs and scientific advice is advantageous


If you are interested in discussing this role further then please email your CV to Rauzan.Iqram@regulatoryprofessionals.com or call Rauzan on 01189 522 979 to arrange a confidential discussion.

If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers*terms and conditions apply.

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