Regulatory Affairs Specialist

About the Role

Our client is seeking a diligent and knowledgeable Regulatory Affairs Specialist to join their expanding team in Milton Keynes . This role is pivotal in ensuring our client's pharmaceutical products meet all necessary regulatory standards for market approval and compliance across various global markets. You will be responsible for preparing regulatory submissions, communicating with health authorities, and staying abreast of evolving regulatory landscapes. This is a remote-first opportunity, allowing you to contribute from anywhere while being an integral part of our Milton Keynes -based regulatory affairs department, promoting efficient and effective global regulatory strategies.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications (NDAs) and variations.
• Liaise with national and international regulatory agencies, responding to queries and facilitating approvals.
• Monitor and interpret regulatory guidelines and advise internal teams on compliance requirements.
• Develop and maintain regulatory submission strategies for product lifecycle management.
• Ensure that all promotional materials and labelling comply with applicable regulations.

Requirements

• Bachelor's degree in a relevant scientific or technical discipline; Master's degree preferred.
• 3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Strong knowledge of FDA, EMA , and other relevant regulatory requirements.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Ability to manage multiple projects and meet tight deadlines in a remote setting.

Benefits

• Competitive salary and potential for annual bonuses.
• Fully remote working environment with flexible hours.
• Comprehensive private healthcare coverage.
• Contributory pension scheme.
• Support for professional development and regulatory training courses.