Regulatory Affairs Specialist

About the Role

Our client is seeking a diligent and experienced Regulatory Affairs Specialist to join their regulatory compliance team in Leeds . This role is critical for ensuring that all pharmaceutical products meet the stringent requirements of regulatory bodies within the UK and international markets. You will be responsible for preparing and submitting regulatory dossiers, managing product registrations, and staying abreast of evolving regulatory landscapes. The ideal candidate possesses a strong understanding of pharmaceutical regulations, meticulous attention to detail, and the ability to navigate complex compliance challenges within the pharmaceutical sector in West Yorkshire .

Key Responsibilities

• Prepare, review, and submit regulatory submissions for new product applications and variations (e.g., MAAs, NDAs).
• Maintain and update product registration files and ensure compliance with current regulations.
• Liaise with regulatory agencies (e.g., MHRA) on submissions, inquiries, and approvals.
• Monitor changes in the regulatory environment and assess their impact on company products and operations.
• Provide regulatory guidance and support to R&D, marketing, and manufacturing departments.
• Ensure that product labeling and promotional materials comply with regulatory requirements.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs .
• Solid understanding of UK and EU pharmaceutical regulatory requirements, including the MHRA guidelines.
• Experience with preparing and filing common regulatory submission types.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to manage multiple projects simultaneously and meet tight deadlines in a fast-paced environment located in Leeds .

Benefits

• Competitive salary and performance bonus.
• Comprehensive private medical, dental, and optical insurance.
• Pension scheme with employer contributions.
• Generous annual leave allowance.
• Opportunities for professional development and training in regulatory affairs.