Regulatory Affairs Associate
- Degree in an associated science subject
- Knowledge of regulatory regulations (optional)
- Ability to prioritise and organise workload
- Strong team-working skills and communication skills (verbally and written)
- Attention to detail and reliable
- Assist the Regulatory Affairs Manager.
- Support administrative requirements of the department.
- Assist in the implementation of the regulatory software system.
- Maintenance of the departmental regulatory database.
- Assisting the Quality Assurance department in maintaining the QMS and various tasks and procedures (OOS, change controls, deviations, CAPAs etc).
- Publishing and tracking of UK/EU regulatory submissions (Type 1A, Type 1B and Type II).
- Archiving of national regulatory submissions and approvals, both electronic and hard copy.
- Support and align with other departments/functions on needs re periodical requests. (e.g., tender support).
- Provide input to local cross functional teams on status of planned, pending and approved regulatory submissions.
- To comply with Health and Safety Regulations.
- To maintain the confidentiality of all information relating to the business activities of the Company (and sister companies).
- To perform other duties as directed by the Company.
- On the job training