Regulatory Affairs Officer

The purpose of this role is to support and maintain Nova’s Licensed product registrations. To coordinate the management, administration and maintenance of Packaging and Labelling for Nova Licensed Products, support the registration of new Medicinal Products with the relevant Competent Authorities and support the growth and implementation of Nova’s Regulatory Strategy for marketed products.

Main duties / responsibilities
- To coordinate changes to SmPC/Labels/Cartons for registered products
- Liaise directly with EMA / MHRA and similar regulatory bodies
- Ensure appropriate change control is in place and executed for packaging changes (and work closely with QA in this respect)
- Liaise with other members of QA, Distributors, Operations and Purchasing departments regarding changes
- Support regulatory filing activities (scientific advice, orphan designation, paediatric investigation plans, marketing authorisation) to MHRA, EMA and other regulatory bodies
- Support regulatory variations and communications with regulators/manage incoming questions
- Provide strategic regulatory advice for products in development (or develop regulatory strategy in conjunction with the Senior Regulatory Affairs Officer)
- Co-ordinate mock-up product information and packaging for products prior to marketing approval - e.g. drafting the SmPC and PIL
- Provide regulatory review and approval of marketing material
- Liaise closely with the Head of Clinical Development (dotted line relationship)
- Preparing essential regulatory documents
- Tracking, distributing and filing of Regulatory documents.
- Liaison with Nova Clinical regarding those areas or studies impacting new or prospective submissions
- Developing close relationships and integrated processes with QA for the implementation of registered, approved changes to marketed products
- Ensuring documents are translated accurately for different markets
- Supporting the Head of QA and Clinical Lead in ensuring that Nova maintain compliance with its regulatory filings and obligations
- Science based degree or equivalent experience in a Regulatory Affairs Role
- Experience of working in a highly regulated industry (e.g. Pharma, Healthcare, or Food).
- An appreciation of Good Manufacturing Practice (GMP).
- The ability to strictly adhere to procedures and a high level of attention to detail.
- Professional and motivated to develop themselves to become an integral part of the team
- Willing to work flexibly to meet the needs of the Department.

**Job Types**: Full-time, Permanent

**Benefits**:

- Company pension

Schedule:

- Day shift
- Monday to Friday

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Wigston: reliably commute or plan to relocate before starting work (required)

**Experience**:

- Regulatory Affairs: 2 years (required)

Work Location: In person