Regulatory Affairs Specialist

About the Role

Our client is actively seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join their fully remote team, supporting operations across the UK. In this critical role, you will be responsible for ensuring that all pharmaceutical products meet stringent regulatory requirements for market approval and compliance. You will navigate complex regulatory landscapes, prepare submission dossiers, and liaise with health authorities to facilitate the timely launch of innovative medicines. This is an exceptional opportunity to contribute to global health initiatives from the convenience of your own home, working with a forward-thinking organization that values expertise and autonomy.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for new product registrations and variations.
• Interpret and apply relevant national and international pharmaceutical regulations.
• Serve as the primary point of contact for regulatory health authorities, managing inquiries and responses.
• Develop and implement regulatory strategies to support product development and lifecycle management.
• Ensure ongoing compliance with all applicable regulatory requirements for products marketed in the UK .
• Collaborate with internal teams to ensure regulatory considerations are integrated into product development plans.

Requirements

• Degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 4 years of experience in pharmaceutical Regulatory Affairs .
• Proven experience in preparing and submitting marketing authorization applications (e.g., MAA, NDA).
• In-depth knowledge of EU and UK regulatory frameworks.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently and manage workload effectively in a remote setting.

Benefits

• Competitive salary and benefits package.
• Fully remote working arrangement, offering excellent work-life balance.
• Opportunity to work on diverse and innovative pharmaceutical products.
• Professional development support and training opportunities.
• Collaborative virtual team environment with regular virtual interactions and support.