Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is seeking a detail-oriented Regulatory Affairs Specialist to join their compliance team in Liverpool . This vital role ensures that all pharmaceutical products and processes adhere to the strict regulations set forth by national and international health authorities. You will be responsible for preparing and submitting regulatory dossiers, maintaining compliance documentation, and staying abreast of evolving regulatory landscapes. This position is ideal for a professional who thrives on ensuring compliance and navigating the complex world of pharmaceutical regulations within a collaborative office setting.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., MAAs, NDAs, variations) to health authorities such as the MHRA, EMA, and FDA.
• Maintain regulatory documentation and databases, ensuring accuracy and completeness.
• Monitor and interpret new and evolving regulatory guidelines and legislation impacting the pharmaceutical industry.
• Liaise with internal departments (e.g., R&D, Manufacturing, Quality Assurance) to gather necessary information for submissions and ensure compliance.
• Respond to queries from regulatory agencies and manage post-approval regulatory activities.
• Provide regulatory guidance and support to project teams throughout the product lifecycle.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related field.
• Minimum of 3 years of experience in pharmaceutical regulatory affairs .
• Strong knowledge of global regulatory submission requirements and processes (e.g., CTD format).
• Familiarity with major regulatory authorities and their guidelines (e.g., MHRA, EMA, FDA).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to manage multiple projects and meet tight deadlines in a structured Liverpool office environment.

Benefits

• Competitive annual salary and benefits package.
• Performance-related bonus opportunities.
• Generous holiday allowance and other company benefits.
• Opportunities for professional growth and continuous learning in regulatory affairs.
• A professional and supportive working environment at our Liverpool facility.