Open roleExternal
Regulatory Affairs Specialist
- southampton, hampshire, SO14, United Kingdom
- Permanent·On-site
- Full time
- £49,000 - £49,000 Per Annum
Job Description
About the Role
Our client is looking for a meticulous and proactive Regulatory Affairs Specialist to join their compliance team in Southampton . This role is essential for ensuring that all of our client's pharmaceutical products meet the complex and evolving regulatory requirements across various global markets. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and providing regulatory guidance to internal teams. This is a critical position for a professional seeking to make a significant impact on product approvals and market access in the pharmaceutical industry within the Southampton region.
Key Responsibilities
- Prepare, review, and submit regulatory submissions (e.g., NDAs, MAAs, variations) to health authorities.
- Interpret and advise on the impact of new or updated regulatory guidelines and legislation.
- Maintain regulatory documentation and databases, ensuring accuracy and completeness.
- Liaise with global regulatory agencies and internal departments to facilitate product registration and lifecycle management.
- Provide regulatory support for product development, manufacturing, and marketing activities.
- Conduct regulatory intelligence activities to stay abreast of industry trends and changes.
Requirements
- Bachelor's degree in Pharmacy, Life Sciences, or a related field.
- Proven experience in pharmaceutical regulatory affairs , including submission preparation.
- In-depth knowledge of global regulatory requirements (e.g., FDA, EMA, MHRA).
- Excellent attention to detail and strong organizational skills.
- Proficiency in regulatory submission software and database management.
- Effective communication and negotiation skills.
Benefits
- Competitive salary range and annual bonus potential.
- Comprehensive medical, dental, and vision benefits.
- Generous paid time off and flexible working options.
- Support for regulatory training and professional certifications.
- A dynamic and challenging work environment in Southampton .