Labelling and Compliance Manager, Biotech - London
A Labelling & Compliance Manager is sought for a top Biotech Company in Central London. This is an excellent opportunity for a Manager/Project Manager or perhaps a top-end Senior Regulatory Officer with a background in Regional Product Labelling and Compliance activity!!
Officering a competitive salary package, this organisation seeks an ambitious individual; you will have experience in: Planning and managing all Regulatory Affairs activity associated with maintenance of Company Core Datasheets; You will have prepared relevant documentation for safety submissions (Type Ia, Ib and II Variations, PSUR's etc.) and liaising with all relevant departments to ensure that Regulatory requirements for these submission are addressed; you will have managed processes through which safety related Regulatory activities are planned, agreed, and progressed; Coordination of all QMS related Regulatory activities to ensure compliance with all activity. Liaison with all relevant internal departments.
Operating as subject matter expert on Labelling process operations excellence and Compliance issues, you will be accountable for implementing process improvements, and the management and development of SOP's and WI's to support inspections. Liaising with the Global Labelling Strategy Team (Europe, USA and International) you will be accountable for management of the European linguistic process, readability requirements, packaging and Labelling reviews. In addition, you will also support the review of communications and promotional materials for compliance with approved Labelling.
If you are a self-starting Labelling Specialist, possessing 5+ years, this is the role for you. You will have a thorough understanding and working knowledge of Labelling, CCDS, Compliance, Prescribing Information, Type Ia, Ib and II Variations, PSUR's. Life-cycle management Communications and Promotional Material.
Ideally, 5+ years solid Labelling and Compliance experience. Working knowledge of Pharma or Biologic Products.
A highly competitive salary package in offered, including bonus and benefits.
If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on the Telephone Numbers provided or by Email, or by clicking Apply Now.
This job was originally posted as www.jobsite.co.uk/job/959456521