Achieva currently have an opportunity for a Regulatory Affairs Officer to join a medium-sized Pharmaceutical company.
Our client will be looking to for regulatory affairs officer to ensure the appropriate licensing of all post approval activities assigned products and to manage development projects for new submissions and variations in order to control their quality, safety and efficacy, in line with business objectives, relevant regulatory requirements and internal and external standards.
- Quality submissions made in line with local and/or corporate timelines and in compliance with local SOPs and defined
- Review and submit clear arguments and explanations for new product licences and licence renewals with the support of senior member of the department
- Performs routine regulatory activities (i.e. maintenance/ renewals/variations)
- Notifies stakeholders of regulatory submission and approvals in a timely manner to ensure project completion
- Recommend changes for labelling, and/or manufacturing for regulatory compliance
- Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities.
- Prepares and maintains a consolidated Module 3 quality dossier for Quality/QP review as per SOP?s.
- Prepare/review SOP?s where required.
- Degree in a suitable scientific discipline (biological/chemistry/life sciences)
- Basic knowledge of UK and European regulatory affairs/PV legislation and guidance
- Planning and organisation skills with the ability to multitask
- Able to work under pressure and to strict deadlines
- Good written communication skills with attention to
- Knowledge of UK and European regulatory affairs/PV legislation and guidance
- Able to build relationships at all levels of the business
- Excellent written communication skills with attention to
- Ability to handle multiple tasks/projects/regulatory submissions and manage priorities.
Please Contact me on +44 1727 817600 or firstname.lastname@example.org
- Agency: Achieva Group Limited
- Contact: Fandi Hatib
- Phone: +44 (0)1727 811 634
- Reference: 30147-1
Website: Achieva Group Limited
- Posted: 5th October 2021
- Expires: 2nd November 2021