Regulatory Labelling Graduate
Job Type:
12 Months Fixed Term Contract
Hours of work:
Mon – Fri (37.5 hours a week)
Industry:
Pharmaceuticals
Location:
Bracknell, England
Salary:
£30,000 per annum
Onsite Requirements:
3 days per week on site
Job Purpose
:
To support the performance of pre-and-post-approval regulatory activities to ensure compliance whilst considering business needs.
To support the creation of packaging component artworks (e.g. folding boxes, labels, information leaflets) in accordance with brand and regulatory guidelines, coordination of internal sign off for printing.
Major Accountability
* The processing and clear communication of regulatory approvals to internal and external stakeholders.
* Monitoring and supporting departmental projects in line with KPIs.
* Working in accordance with Global and local Working Instructions and SOPs.
* Carrying out other activities which contribute to the effective performance of the Regulatory Affairs Department.
* Working with the Regulatory Affairs team to ensure requests for packaging artworks are progressed effectively to meet deadlines.
* Ensuring all packaging artwork is created and processed in accordance with regulatory guidelines and operating procedures.
* Co-ordination of packaging changes with internal and external printers.
* Management and prioritisation of packaging component sign off to ensure timely implementation in line with regulatory requirements.
* Provision of support for departmental and cross-functional projects
Education & Qualifications:
* BSc / MSc in Life Sciences
Experience:
* Essential:
* Ability to be flexible and multi-task within a fast-paced environment.
* Considerable attention to detail
* An understanding of project management.
* Can effectively cope with change in a fast-moving business.
* Can write clearly and succinctly in a variety of communication settings and styles.
* Can get messages across that have the desired effect.
* Desirable:
* Experience in Regulatory Affairs within a Generic or Pharma business.
* Knowledge of Adobe programmes: Illustrator, InDesign, Quark, Photoshop and Filemaker