Regulatory Affairs Specialist

About the Role

Our client is seeking a knowledgeable and strategic Regulatory Affairs Specialist to join their growing team, supporting operations in Leeds . This role is integral to ensuring that our client's pharmaceutical products comply with all relevant national and international regulations throughout their lifecycle. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and providing regulatory guidance to internal development and commercial teams. This is an excellent opportunity for a seasoned regulatory professional to make a significant impact on product approvals and market access within the vibrant West Yorkshire pharmaceutical landscape.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., MAA, NDA, variations) to health authorities worldwide.
• Interpret regulatory guidelines and provide strategic advice on regulatory requirements for product development and lifecycle management.
• Act as a primary point of contact with regulatory agencies, managing communications and responses to queries.
• Ensure compliance of product labeling, advertising, and promotional materials with regulatory standards.
• Develop and maintain regulatory documentation and databases.
• Collaborate with cross-functional teams, including R&D, quality assurance, and commercial departments, to align regulatory strategies.

Requirements

• Bachelor's degree in a science-related field; Master's or higher preferred.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and managing various types of regulatory submissions.
• In-depth knowledge of global regulatory requirements (e.g., EMA, FDA).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work effectively in a remote setting, managing time and priorities independently.

Benefits

• Competitive annual salary commensurate with experience.
• Flexible working arrangements, including a fully remote option.
• Comprehensive private medical insurance.
• Generous holiday allowance and company sick pay.
• Opportunities for professional growth and international exposure in the Leeds region.