Open roleExternal
Regulatory Affairs Specialist
- portsmouth, hampshire, PO1, United Kingdom
- Permanent·Remote
- Full time
- £62,000 - £62,000 Per Annum
Job Description
About the Role
Our client is looking for a detail-oriented Regulatory Affairs Specialist to join their fully remote team, supporting their operations with a focus on the Portsmouth market. This role is crucial for ensuring that all pharmaceutical products comply with the complex and evolving regulatory landscape. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and providing strategic guidance on regulatory requirements. The ideal candidate possesses strong analytical skills, excellent communication abilities, and a thorough understanding of pharmaceutical regulations, thriving in an independent, remote work setting.
Key Responsibilities
- Prepare, review, and submit regulatory documentation for new product registrations and variations.
- Liaise with regulatory agencies (e.g., MHRA, EMA) to facilitate approvals and address queries.
- Monitor changes in regulatory legislation and guidelines, assessing their impact on the company's products.
- Ensure ongoing compliance of marketed products with relevant regulations.
- Provide regulatory input and support to cross-functional teams, including R&D, marketing, and manufacturing.
- Maintain regulatory databases and records.
Requirements
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 3 years of experience in pharmaceutical regulatory affairs.
- Thorough knowledge of UK and European regulatory requirements for pharmaceuticals.
- Experience with regulatory submission formats (e.g., CTD).
- Excellent written and verbal communication skills, with strong attention to detail.
- Ability to work independently and manage multiple projects effectively in a remote environment.
Benefits
- Competitive salary package.
- Fully remote working position offering excellent work-life balance.
- Comprehensive health, dental, and vision insurance.
- Pension scheme with employer contributions.
- Opportunities for professional development and attending industry conferences.