Senior Regulatory Specialist

Parkside Recruitment; Windsor; On-site; GBP 75,000 - 110,000; Full time

Job summary

Parkside Recruitment seeks an experienced Regulatory Affairs Manager to lead regulatory activities across the UK affiliate. You will drive regulatory strategy, manage a high-performing team, and represent the organization with MHRA and other authorities.

Collaborating with UK, EU and Global stakeholders, you will guide regulatory planning, ensure compliance, and advance lifecycle management of a diverse pharmaceutical portfolio. Strong leadership and regulatory expertise are essential.

Qualifications

• Degree in Life Sciences is required
• Approximately 7 years of regulatory affairs experience in pharma
• Experience with CTD documentation, MAAs, national and centralised procedures
• Strong understanding of post-marketing activities
• Experience interacting with MHRA and managing regulator responses
• Knowledge of SmPCs, PILs, labeling requirements and regulatory compliance processes
• Strong project management, organizational and stakeholder management skills
• Ability to influence cross-functional teams in a global environment
• Experience writing SOPs and improving regulatory processes

Responsibilities

• Lead UK regulatory activities for marketed products including strategy, submissions, approvals and lifecycle management
• Prepare, review and submit regulatory documentation such as CTD dossiers and post-authorisation activities
• Lead regulatory projects including registrations, variations, renewals, scientific advice meetings, PIPs and Orphan Drug Designations
• Provide regulatory input into product development strategies and EU/UK regulatory planning
• Represent Regulatory Affairs in cross-functional teams and advise on regulatory requirements and risks
• Manage interactions with MHRA including responses to questions and meetings
• Maintain regulatory databases, trackers, SOPs and controlled documents
• Support labeling activities including SmPCs, PILs and product information updates
• Drive continuous improvement of regulatory processes and audit readiness

Skills

Regulatory Affairs

CTD documentation

Regulatory submissions

Stakeholder management

Project management

Cross-functional collaboration

Education

Degree in Life Sciences

Job description

We are seeking an experienced Regulatory Affairs Manager to lead regulatory activities across our UK affiliate. This is an exciting opportunity to play a pivotal role in ensuring regulatory compliance, driving regulatory strategy, and supporting the lifecycle management of a diverse pharmaceutical portfolio.

Working closely with UK, European and Global stakeholders, you will provide expert regulatory leadership, manage a high-performing Regulatory Affairs team, and represent the organisation in interactions with the MHRA and other regulatory authorities.

Key Responsibilitie

• sLead UK regulatory activities for marketed products, including regulatory strategy, submissions, approvals and lifecycle management
• .Manage preparation, review and submission of regulatory documentation, including CTD dossiers and post-authorisation activities
• .Lead regulatory projects including new registrations, variations, renewals, Scientific Advice meetings, PIPs and Orphan Drug Designations
• .Provide regulatory input into product development strategies and support EU/UK regulatory planning
• .Represent Regulatory Affairs in cross-functional teams and provide expert advice on regulatory requirements and risks
• .Manage interactions with the MHRA, including responses to regulatory questions and meetings
• .Ensure regulatory databases, trackers, SOPs and controlled documents are maintained and compliant
• .Support labelling activities, including SmPCs, PILs and product information updates
• .Drive continuous improvement of regulatory processes and support audit readiness

.
Essential Experience & Skil

• lsDegree in Life Sciences or a related scientific disciplin
• e.Approximately 7 years’ experience in Regulatory Affairs within the pharmaceutical industr
• y.Experience with CTD documentation, MAAs, national and centralised procedure
• s.Strong understanding of post-marketing activiti
• esExperience interacting with the MHRA and managing regulatory authority response
• s.Knowledge of SmPCs, PILs, labelling requirements and regulatory compliance processe
• s.Strong project management, organisational and stakeholder management skill
• s.Ability to influence cross-functional teams and work effectively in a global environmen
• t.Experience writing SOPs, improving processes and maintaining regulatory complianc