Regulatory Affairs Specialist

1 week ago

Salisbury, United Kingdom Porton Biopharma Full time

Porton Biopharma Ltd, Porton Down is a medium sized life-science company performing a range development and manufacturing roles for biopharmaceuticals. This also includes all associated support functions from logistics through to engineering, quality control / quality assurance, regulatory affairs and management.

The Company manufactures two licensed products, Erwinase® and the UK’s Anthrax Vaccine as well as providing R&D services for product development. The Regulatory Affairs & Pharmacovigilance Directorate are responsible for Regulatory Affairs, Market Access, Pharmacovigilance and Medical Information including management of Porton Biopharma’s licenses and marketing authorisations

The Regulatory Affairs Specialist will take a leading role in Regulatory activities, including labelling and clinical, to manage PBL’s regulatory commitments in relation to approved and pipeline medicinal products. This will include preparation and review of submissions and associated technical documents, and also acting as the Regulatory team representative on project teams. In addition, review of change controls from a regulatory perspective will be required.

The individual is expected to be able to regularly synthesize key analytical outputs in management-ready deliverables to help inform and drive strategic business decisions. The individual is expected to have a strong grasp of the highly regulated biopharmaceutical industry.

To be considered for this role, we require:

- A current right to work in the UK.
- Degree in life sciences, chemistry, or pharmacy
- Excellent communication skills at all levels.
- Evidence of Continuing Professional Development
- More than 5 years’ experience in the pharmaceutical industry, and more than 3 years’ experience in Regulatory Affairs
- Strong IT skills, always being ahead of new technologies
- Energetic, highly motivated, with an enquiring mind and passion for excellence and innovation in pursuit of business growth and success
- Ability to work under pressure, consistently meeting tight deadlines and able to offer practical solutions

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

**Salary**: From £42,000.00 per year

**Benefits**:

- Casual dress
- Childcare
- Company pension
- Cycle to work scheme
- Discounted or free food
- Free or subsidised travel
- Life insurance
- On-site parking
- Private medical insurance
- Store discounts
Schedule:

- Monday to Friday
**Experience**:

- Regulatory Affairs: 3 years (preferred)
Work authorisation:

- United Kingdom (required)

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