EU CTA) Regulatory Affairs Manager Contract)

(EU CTA) Regulatory Affairs Manager Contract)

I have an exciting opportunity for a Regulatory Affairs Manager with submission experience of EU centralized applications and PIPS to join my client on a contract biases in Cambridge.

Essential Duties and Job Functions:
Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs for investigational and commercial products in Europe, in accordance with regional requirements and scientific and company policies and procedures.
Responsible for submitting moderately complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications in Europe and marketing authorizations for assigned territories (Mainly EU Centralized).
Responsible for ensuring that any updates to the CCDS and the Product Company Core Safety Information (CCSI) are implemented.
Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license.
Acts as project team representative for specified products depending on complexity of the project.
May provide strategic regulatory advice as appropriate.
Maintains knowledge of regulatory requirements up to date and communicates changes in regulatory information to project teams and senior management in a timely manner.
May initiate local process improvements and contribute to local and/or global process improvements, which have a moderate impact on the Regulatory Affairs function or other departments.
Plans, schedules and arranges own activities.

Knowledge, Experience and Skills:
Typically requires a BA/Bsc degree or higher in relevant discipline in Regulatory Affairs or related field.
Direct experience working with Regulatory Authorities in assigned territories is desirable.
Must be knowledgeable of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
Must be capable of developing and implementing regulatory strategy and of managing negotiations with Regulatory Authorities.
May take a leadership role in updating and preparing the Company for minor changes in legislation in assigned territories.
Work is performed under limited direction of a senior Regulatory Affairs professional.
Is recognized as a knowledgeable resource for Regulatory Advice on specific topics in other departments.
Multiple submission experience with EU Centralized applications.
PIPS application experience.

If you are interested in the above role and want to hear more, please send an up to date CV along with contact number or call me directly to avoid disappointment.

I am a specialist recruiter that operates within the European Pharma space and work with a range of different Biotech companies, Pharmas and CROs. If you are currently considering what other opportunities may be available to yourself, please feel free to get in contact for a confidential discussion.

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.