Regional Regulatory Affairs Business Officer

The Regional Regulatory Affairs Business Officer will provide support to the senior management team of Soho Flordis UK in all compliance and regulatory matters.

Key responsibilities and accountabilities:

• Manage and maintenance of the company’s Manufacturing and Wholesale Dealers Authorisations in addition to the portfolio of Authorised products
• Provide guidance to site Management team on regulatory compliance issues shared with QP, Quality Manager and external consultants
• Build relationships and successfully liaise with the UK MHRA in order to transfer relevant information
• Prepare and submit variations as and when required
• Ensure compliance with new regulatory requirements, as they are issued/updated by the regulatory authorities and communicate they to relevant departments
• Ensure post approval commitments are logged and acted upon
• Provide regulatory requirements and timelines on SFI UK local portfolio/manufacturing NPD projects
• Participate and support in regulatory inspections by the competent authority and customers
• Ownership of the artwork process outlining requirements for labelling, and packaging
• Develop and write Regulatory SOP’s
• Ensure critical regulatory documents are maintained and reviewed on a regular basis e.g. BSE/TSE statements, Supply Chain Maps and API declarations

Skills, knowledge and experience:

• 3 years + of Regulatory Affairs experience in complementary medicines and dietary supplements
• Project management skills
• Strong attention to details and results-oriented attitude
• Excellent communication skills (verbal and written), comfortable in dealing with key stakeholders
• Understanding of natural medicines and passion for clinically proven natural medicines
• Strong commercial focus and ability to solve regulatory challenges in commercial situations

Location of Position:

The role will be based in Wigan (UK)

Who to Contact:

Send your applications to: [email protected]