Regulatory Affairs Officer

4 weeks ago

Petersfield, United Kingdom Aspire Pharma Full time

**Salary**: Competitive salary

**Hours of Work**: Monday - Friday: 9.00am-5.00pm

**Contract Type**:Full Time, Permanent

**Regulatory Affairs Officer Duties**:

- **Control of Documentation** - to ensure that medicinal product dossiers and MD technical files are appropriately maintained and updated; to act as a signatory on technical files documentation; to review and approve batch manufacturing recordsand to contribute to health technology assessment and clinical trial submissions where applicable.
- **Regulatory Intelligence** - maintaining awareness of existing and new legislation/ guidance relating to UK and EU legislation on Medicines and Medical Devices and to ensure compliance with all regulatory requirements where applicable. Suchas EU Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP).
- **Quality Policy** - to maintain compliance with the company Quality policy and objectives, and applicable internal processes as per the Quality Management System (QMS). Ensuring compliance with EU GMP, GDP, GCP and GVP. Provide support tothe Quality Team in product quality reviews, change controls, non-conformance/deviations and CAPAs, and SOPs, as required.

**Regulatory Affairs Officer Requirements**:

- Educated to degree or equivalent level within life sciences or chemistry
- Good IT skills including MS Word, Excel and PowerPoint;
- Accuracy and attention to detail;
- Strong problem-solving skills and ability to work independently;
- Good communication skills, both written and verbal.

**Regulatory Affairs Officer Benefits**:
Complementing your salary, we also offer a variety of benefits and services to support your physical and mental well-being which include:

- Bonus scheme;
- Life Assurance cover of 4 x annual salary;
- Opportunities for professional development;
- Hybrid working available (up to 2 days at home) after an initial training period;
- Company events and celebrations throughout the year;
- 2 Corporate Social Responsibility (CSR) days per calendar year to volunteer in community projects;
- On-site parking.

**About the Company**:

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