Regulatory Assistant

3 months ago

Ilkeston, United Kingdom Weleda (UK) Ltd Full time

Job Advert

The Regulatory Assistant will work alongside 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 onto the UK portal, ensuring the Product Information Files are kept up to date and maintenance of 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 departments 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. Natrue
- 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 of Change Controls from Weleda Group
- PO raising and maintenance of the Regulatory Departments 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, Specials 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 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.

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