Regulatory Affairs Associate

Recruiter
SEC Recruitment
Location
Cambridgeshire
Posted
10 Feb 2018
Closes
15 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Role: Freelance Regulatory Affairs AssociateLocation: Office based in Cambridgeshire Contract length: Up to 12 MonthsMy client is a Biopharmaceutical organisation who are specialist in discovering and developing innovative medicines in therapeutic areas such as HIV/AIDS, Liver Diseases, Oncology and Inflammation, serious Respiratory and Cardiovascular conditions. This role has arisen due to increased workload, where you will be joining a fun, dynamic and diverse growing company who are looking for a Regulatory Affairs Associate to join their expanding RA team.Duties: • Working within a European therapeutic group within International markets• Responsible for the preparation of Regulatory Submissions• Prepare non-clinical, clinical and safety RA documentation, when required, in accordance to regulations• Responsible for post licencing commitments and legal obligations of marketing authorisations holder via the EU centralised procedure, e.g. variations, renewals, responses to questions, follow – up measures, PSURs. • Prepare regulatory documentation to support CTA• Ensure product packaging and associated information is updated and maintained in accordance with marketing authorisation including the review and management of labelling translations and artwork• To participate in RA team meetings, product team meetings and study management team meetings (for CTAs)• Responsible for gaining and maintaining a broad knowledge requirements and guidelines for communicating changes in regulatory information to product teams.The ideal candidates must have already established experience in EU Centralised Procedures, CTA, Marketing Authorisations and to be hands on with Regulatory Submissions & RA Documentation. Also, as a Regulatory professional, a Degree in Biological/Life Sciences or Pharmacy is mandatory.If you have experience in the above and working within European Medicines Agency along with representing RA on cross-functional teams then please apply or if you would like more information around the role or a confidential chat then please call me on 0207 255 6600 or email me on natasha.mankoo@secpharma.com

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