Senior Regulatory Affairs Officer
Oliver Care at CK Clinical is recruiting for a Senior Regulatory Affairs Officer to join a company in the pharmaceutical industry at their site based near Edinburgh on a 12 months fixed term contract basis.
The main purpose of your role will be:- To prepare and maintain regulatory documentation and materials in compliance with Good manufacturing practice (cGMP), ISO9001 and ISO13485, the IVD Directive 98/79/EC, Good Clinical Practice (GCP) and approved Health and Safety Policies.
- To be responsible for developing and maintaining product labelling requirements for products and for customer contracted products including but not limited to package labels, product labels and instructions for use.
- To liaise with the internal team members, regulatory agencies and external customers to provide information to support worldwide registration.
Further responsibilities will include:
- To maintain good working knowledge of regulatory requirements, keeping abreast of updates to regulation worldwide and advise as appropriate.
- To actively participate in product development projects on a regular basis in order to provide guidance on regulatory requirements and to provide supporting regulatory documentation.
- To conduct all duties in compliance with cGMP, ISO 13485, ISO9001, GCP, Good Documentation Practice (GDP) and appropriate regulatory requirements.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A relevant degree and work experience in regulatory affairs environment.
- Sound knowledge and expertise with core IT packages i.e. MS Office.
For more information or to apply for this position, please contact Oliver Care on 01438 743047 or email firstname.lastname@example.org. Alternatively please click on the link below to apply online.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL33599 in all correspondence.