<p>A Regulatory Affairs Specialist ensures that products meet all applicable regulatory requirements from development through post-market. This role liaises with regulatory agencies, prepares submissions, and advises cross-functional teams to achieve timely approvals. The ideal candidate is detail oriented, organised and experienced in UK and EU regulatory frameworks.</p>
<p>This job description outlines the responsibilities, required skills and qualifications for a Regulatory Affairs Specialist. It is intended for HR professionals, recruiters and staffing agencies seeking to hire top candidates who can ensure product compliance and regulatory success.</p>
<h2>Regulatory Affairs Specialist Job Profile</h2>
<p>The Regulatory Affairs Specialist is responsible for planning and executing regulatory strategies for medicinal products, medical devices or combination products. They prepare dossiers, manage submissions and communicate with regulatory authorities to obtain marketing authorisations and maintain compliance throughout the product lifecycle.</p>
<p>This role requires strong technical knowledge, excellent written communication skills and the ability to work with multidisciplinary teams including quality, clinical and manufacturing functions. The specialist must keep abreast of evolving regulations and provide pragmatic advice to support business objectives.</p>
<h2>Regulatory Affairs Specialist Job Description</h2>
<p>The Regulatory Affairs Specialist will develop and implement regulatory plans to support product development and market access in the UK and, where applicable, the EU and other territories. Core duties include preparing regulatory submissions such as marketing authorisation applications, variations, technical files and regulatory correspondence. The specialist will compile and review regulatory documentation to ensure accuracy, completeness and compliance with local and international requirements.</p>
<p>Working closely with project teams, the specialist will advise on regulatory implications of clinical study designs, labelling, advertising and post-market obligations. They will coordinate responses to regulatory queries, manage timelines for submissions and maintain regulatory master files. The role often requires liaison with notified bodies, the MHRA and other competent authorities to secure approvals and resolve regulatory issues efficiently.</p>
<p>Additionally, the Regulatory Affairs Specialist monitors regulatory intelligence and updates internal processes to reflect new guidance and legislation. They contribute to risk assessments and work with quality assurance to support audits and inspections. The post demands an analytical mindset, meticulous documentation practices and the capacity to prioritise tasks in a deadline driven environment.</p>
<h2>Regulatory Affairs Specialist Duties and Responsibilities</h2>
<ul>
<li>Develop and implement regulatory strategies for product submissions and maintenance.</li>
<li>Prepare and submit marketing authorisation applications, variations and notifications.</li>
<li>Compile and review regulatory dossiers, technical files and clinical study documentation.</li>
<li>Manage regulatory timelines and coordinate cross functional input to meet submission deadlines.</li>
<li>Respond to queries from regulatory authorities and coordinate inspections or audits.</li>
<li>Advise on labelling, packaging and advertising to ensure regulatory compliance.</li>
<li>Monitor regulatory changes and provide updates to stakeholders and internal teams.</li>
<li>Maintain regulatory master files and ensure accurate record keeping.</li>
<li>Support post market surveillance, vigilance reporting and risk management activities.</li>
<li>Provide training and guidance on regulatory requirements to colleagues.</li>
</ul>
<h2>Regulatory Affairs Specialist Requirements and Qualifications</h2>
<ul>
<li>Bachelor's degree in life sciences, pharmacy, chemistry or a related discipline; relevant postgraduate qualification desirable.</li>
<li>Proven experience in regulatory affairs within pharmaceuticals, medical devices or combination products.</li>
<li>Strong knowledge of UK and EU regulatory frameworks, submission formats and guidelines.</li>
<li>Excellent written and verbal communication skills with the ability to prepare high quality regulatory documents.</li>
<li>Attention to detail, good organisational skills and the ability to manage multiple projects simultaneously.</li>
<li>Experience working with regulatory authorities such as the MHRA or EMA.</li>
<li>Proficiency with electronic submission systems and common office software.</li>
<li>Ability to analyse complex data and provide clear regulatory advice to commercial and technical teams.</li>
<li>Commitment to continuous professional development and staying current with regulatory changes.</li>
</ul>