Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is seeking a proactive and experienced Regulatory Affairs Specialist to manage and execute regulatory strategies for pharmaceutical products in Southampton . You will be responsible for ensuring compliance with national and international regulatory requirements throughout the product lifecycle, from development to post-market surveillance. This role involves preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulations. It's an excellent opportunity for a regulatory professional to contribute to bringing vital medicines to market, working within a well-established pharmaceutical company dedicated to patient well-being.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, MAA, NDA) to health authorities in various markets.
• Liaise effectively with regulatory agencies (e.g., MHRA, EMA) to facilitate the approval process.
• Monitor and interpret regulatory guidelines and advise the company on compliance strategies.
• Manage post-approval regulatory activities, including variations, renewals, and annual reports.
• Collaborate with cross-functional teams (R&D, Manufacturing, Marketing) to ensure regulatory requirements are met.
• Maintain regulatory databases and ensure accurate record-keeping.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of regulatory submission requirements and guidelines (e.g., ICH, FDA, EMA, MHRA).
• Experience with preparing and submitting regulatory dossiers.
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple projects and meet strict deadlines in a fast-paced environment.

Benefits

• Competitive salary and potential for performance-based increases.
• Comprehensive health, dental, and vision insurance plans.
• Pension scheme and life insurance benefits.
• Opportunities for career advancement and professional training.
• Relocation assistance may be available for exceptional candidates.
• Work in a dynamic team focused on global regulatory excellence in Southampton .