Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is seeking a knowledgeable and detail-oriented Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance for their pharmaceutical products in the Norwich region. This vital role involves navigating complex regulatory landscapes, preparing submission dossiers, and liaising with health authorities such as the MHRA. You will play a key role in bringing new and existing medications to market, ensuring they meet all necessary legal and scientific requirements. This is an excellent opportunity to contribute to the pharmaceutical industry within Norfolk , working within a team dedicated to bringing innovative treatments to patients.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for product registration, variations, and renewals to health authorities.
• Ensure all company products and processes comply with current national and international pharmaceutical regulations.
• Liaise with regulatory agencies to respond to queries and facilitate the approval process.
• Monitor changes in the regulatory environment and assess their impact on company products and operations.
• Collaborate with internal departments, including R&D, Quality Assurance, and Marketing, on regulatory strategy and compliance matters.
• Maintain regulatory databases and ensure accurate record-keeping of all submission activities.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Proven experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Strong understanding of regulatory requirements and submission processes in key markets (e.g., UK , EU).
• Experience with the preparation of Common Technical Document (CTD) modules.
• Excellent analytical, organizational, and written communication skills.
• Ability to work independently and manage multiple projects in a fast-paced environment.

Benefits

• Competitive salary and comprehensive benefits package.
• Opportunity to work on a diverse portfolio of pharmaceutical products.
• Professional development and continuous learning opportunities.
• Pension scheme and life assurance.
• A collaborative and supportive team environment.