Kelly Science, Engineering, Technology & Telecom
Regulatory Affairs Manager
England
Posted about 18 hours ago
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Role Overview
The Regulatory Affairs Manager is responsible for supporting the regulatory lifecycle of medicinal products across designated markets or regions. This includes obtaining and maintaining the necessary regulatory authorisations for clinical development activities and commercially marketed products, ensuring compliance with applicable legislation, and contributing to regional regulatory strategies.
The role works closely with cross-functional and global stakeholders to support product development, regulatory submissions, interactions with health authorities, and lifecycle management activities.
Key Responsibilities
Regulatory Strategy and Execution
- Develop, coordinate, and manage regional regulatory submissions, including clinical trial applications, marketing authorisation applications, and post-approval variations, in accordance with global development plans and local regulatory requirements.
- Implement product-specific regulatory strategies, processes, and activity plans in line with applicable legislation, regulatory guidance, and organisational procedures.
- Provide regulatory input and content guidance for regional documentation, submissions, and health authority meetings, ensuring alignment with global product strategies.
- Advise on regional regulatory pathways and mechanisms that may facilitate product development, including first-in-human studies, orphan designation, accelerated or conditional approval pathways, compassionate use programmes, and paediatric development plans.
- Contribute to the development and negotiation of regional product labelling, balancing commercial objectives with available scientific evidence, regulatory precedent, and applicable requirements.
- Support the development and implementation of regional regulatory strategies, including assessment of precedents, risk management, and contingency planning.
- Evaluate potential regulatory outcomes, identify risks and opportunities, and provide recommendations to support effective decision-making.
- Advise global development stakeholders on regional regulatory requirements and their implications for clinical development plans and objectives.
- Ensure regulatory approvals and commitments are maintained and that relevant activities are completed within required timelines.
- Where appropriate, provide day-to-day leadership, guidance, or supervision to regional regulatory colleagues and support staff.
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Regulatory Agency Engagement and Collaboration
- Serve as a regional point of contact for relevant health authorities in relation to assigned products and regulatory activities.
- Coordinate regulatory agency interactions and ensure that local regulatory obligations are fulfilled.
- Document, communicate, and follow up on the outcomes of health authority meetings and correspondence with relevant regulatory and senior management stakeholders.
- Represent the regional regulatory perspective within cross-functional teams, including global regulatory, product development, clinical study, and labelling groups.
- Work collaboratively with regional and global colleagues to identify local requirements, resolve regulatory issues, and support consistent execution of product strategies.
- Contribute to the development of product labelling by assessing scientific data, regulatory expectations, established precedents, and regional requirements.
Regulatory Research and Intelligence
- Monitor changes in legislation, regulatory policy, technical guidance, and industry practices that may affect assigned products or development programmes.
- Conduct regulatory research to identify relevant precedents, historical decisions, and other information that may influence regional product development or lifecycle management.
- Assess the potential impact of new or revised regulations, guidance documents, health authority expectations, and competitor labelling.
- Communicate relevant regulatory developments and recommend appropriate actions to maintain compliance and support product objectives.
Team and Working Environment
- The position sits within a regional regulatory affairs function supporting both development-stage and commercially established medicinal products.
- The role works with multidisciplinary colleagues responsible for regulatory strategy, submissions, and product lifecycle management, from early clinical development through marketing authorisation and post-approval maintenance.
- Responsibilities may span several therapeutic areas, including metabolic and cardiovascular conditions, inflammatory diseases, endocrinology, bone health, and biological medicines, including biosimilar development.
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Qualifications and Experience
- A degree in a relevant scientific discipline, such as pharmacy, pharmaceutical sciences, biology, chemistry, or a related life science.
- Demonstrated experience in regulatory affairs or a comparable role within the pharmaceutical or biotechnology industry.
- Practical knowledge of regulatory requirements and procedures applicable to medicinal products.
- Experience working with regulatory policies, standard operating procedures, and quality or compliance processes.
- Understanding of regional regulatory pathways for clinical trial applications, marketing authorisations, post-approval changes, extensions, and renewals.
- Knowledge of pharmaceutical research and development, including clinical development and the transition to commercialisation.
- Experience assessing regional regulatory requirements and their implications for product development and lifecycle management.
- Strong written and verbal communication skills, with the ability to present complex scientific and regulatory information clearly.
- Ability to interpret scientific and clinical data and communicate regulatory implications to diverse stakeholders.
- Strong analytical and problem-solving skills, including the ability to anticipate risks, resolve competing priorities, and develop practical solutions.
- Demonstrated ability to manage stakeholder relationships, navigate conflicting perspectives, and drive decisions towards appropriate outcomes.
- Cultural awareness and the ability to collaborate effectively across countries, regions, and international teams.
Core Competencies
- Regulatory strategy and submission management
- Regional regulatory compliance
- Health authority engagement
- Product labelling and lifecycle management
- Regulatory intelligence and research
- Risk assessment and contingency planning
- Cross-functional stakeholder management
- Scientific and regulatory communication
- International collaboration and cultural awareness
- Leadership and coordination, where applicable
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