Senior Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is seeking an experienced Senior Regulatory Affairs Specialist to manage regulatory submissions and strategy for their pharmaceutical products in Reading . This role is crucial for ensuring timely approval and compliance of medicinal products with global regulatory bodies. You will be responsible for developing regulatory strategies, preparing submission dossiers, and maintaining strong relationships with health authorities. This is an excellent opportunity for a seasoned regulatory professional to take on significant responsibility and drive the success of innovative pharmaceutical products.

Key Responsibilities

• Develop and implement regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, MAA) to health authorities globally.
• Liaise with regulatory agencies, respond to queries, and facilitate meetings with health authorities.
• Monitor and interpret evolving regulatory guidelines and ensure company compliance.
• Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, and manufacturing.
• Manage post-approval changes and ensure ongoing compliance for marketed products in the Reading region and beyond.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry.
• Proven track record of successful regulatory submissions and approvals in major markets (e.g., UK, EU, US).
• In-depth knowledge of pharmaceutical regulations, guidelines, and submission requirements.
• Excellent written and verbal communication skills, with strong negotiation abilities.
• Ability to work independently and manage multiple complex projects simultaneously.

Benefits

• Competitive salary and performance bonus.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holidays.
• Opportunities for international travel and professional development.
• Engaging work on innovative pharmaceutical products.
• Contributory pension scheme.