Regulatory Assistant

Location

Ilkeston, Derbyshire | United Kingdom

Job description

Location: Ilkeston office
Contract Type: Permanent/ Part-time
Salary: £25,000 - £27,000 per annum (FTE), pro-rata (depending on experience)
Hours: 22.5 hours (3 days) per week
Benefits : Competitive

The Regulatory Assistant will support the Regulatory Manager & QPPV ensuring Regulatory compliance of Weleda UK’s product portfolio of medicines, Natural and Organic cosmetics and food supplements. The Regulatory Assistant will be responsible for notifying cosmetic products on the UK portal, ensuring the Product Information Files are kept up to date and maintaining certificates from external bodies.

The Regulatory Assistant will be responsible for drafting and submitting standard variations to the MHRA for Weleda UK’s medicinal products. The role will include the handling of technical information across all product classifications and the execution of the Regulatory Department’s administration tasks.

KEY RESPONSIBILITIES:

• Notification of cosmetic products onto the UK portal to maintain compliance with the relevant legislation
• Maintenance of certifications and re-certifications from external bodies e.g. Nature
• Maintenance of Cosmetic Product Information Files
• Maintenance of all company manufacturing, import and wholesale dealer licences
• The collation, creation and reviewing of technical documents across all product classifications including the drafting and submission of standard variations to the MHRA for Weleda UK’s medicinal products
• Accessing, reviewing and logging Change Controls from Weleda Group
• PO raising and maintenance of the Regulatory Department budget
• Liaison with internal departments including QA and QC as well as external suppliers
• Liaison with Weleda International Regulatory Affairs Group and the Scientific Information and Regulatory Affairs NOC (SCIRA) department at Weleda Group.
• Attendance to relevant meetings and training sessions

PERSON SPECIFICATION:

• At a minimum educated to A-level standard.
• Proven background working in a regulated industry for at least 2 years
• Proven background in reviewing technical documentation
• Good knowledge/understanding of the importance of Regulatory/Quality Compliance
• Awareness of regulations affecting licensed medicines (Traditional Herbal, Homoeopathic Registrations, National Rules, special manufacturing), cosmetics or food supplements is advantageous but not essential
• Strong analytical skills, attention to detail and numerate, comfortable with the review of technical documentation
• Proficient with Microsoft Office (Word, Excel, Outlook, Teams).
• The ability to manage multiple tasks
• The ability to work to tight deadlines and have outstanding time management skills
• Team player, works with all stakeholders to establish and meet shared goals
• Able to communicate effectively at all levels
• Positive, can-do attitude with a pragmatic approach to problem-solving
• Embraces change and looks for win-win opportunities
• In addition to the above, you will have a flexible approach to the job role; be eager to learn new concepts; and be able to think creatively and laterally and outside the box where necessary, in order to complete the tasks in hand to the correct standard.

This position is offered on a part-time basis of 3 days per week (22.5 hrs) and will be based onsite at our Head Office in Ilkeston, Derbyshire

Why work for us:

Weleda was established over one hundred years ago as a place of human development through a common goal - to create natural products that support and enhance health and well-being, profitably.

Today, we operate globally across 50 countries and we are recognised as the industry leader.
We share a common culture founded upon strong sustainable principles for the environment, for the economy and for our personal well-being and development.

This includes adopting a flexible approach to work; acting responsibly, honestly and ethically and placing responsibility on each and every one of us to uphold these values.

You may have experience in the following: Regulatory Compliance Coordinator, Compliance Assistant, Regulatory Affairs Specialist, Regulatory Analyst, Compliance Officer, Regulatory Coordinator, Regulatory Support Specialist, Compliance Specialist, Regulatory Affairs Assistant, Regulatory Compliance Assistant, Regulatory Affairs Coordinator.

REF-212 078

Job tags

Salary

£25k - £27k per annum