Regulatory Affairs Specialist in Reading

Regulatory Affairs Specialist Role reports to: Associate Director, Regulatory Affairs

Location: Europe/Middle East/Africa, United Kingdom, Reading, Berkshire

Work location: Hybrid

What you will do:

• Assist in the development of regulatory strategies across the EMEA region, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.
• Coordinate, compile, and submit new drug applications to regulatory agencies within their geographical and/or brand area of responsibility.
• Manage MRP, DCP, and Workshare submission activities for medicines.
• Develop effective partnerships with R&D, Franchise (Marketing), and local regulatory colleagues.
• Collect and evaluate information on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
• Prepare and submit regulatory submissions for the registration and maintenance of products throughout their lifecycle, according to applicable regulatory requirements and guidelines.
• Monitor the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
• Prioritise, plan, and monitor allocated projects against defined timelines.
• Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements.

Regulatory Compliance:

• Ensure that all assigned products comply with local regulatory and quality system requirements.
• Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
• Stay aware of current regulations and anticipate implications and opportunities arising from changes in the regulatory environment.
• Participate in the development and implementation of applicable processes, SOPs, and working instructions.
• Ensure that enterprise regulatory systems are accurate and fully maintained.
• Review and elevate compliance issues, implementing relevant corrective/preventative actions locally.
• Identify and implement regional process improvement opportunities and ensure the implementation of relevant global or regional regulatory initiatives.
• Assist in the preparation for internal and external audits and inspections in collaboration with others.

Specific Requirements:

• Relevant Bachelor's Degree or higher.
• 4+ years of related regulatory experience.
• Represent Regulatory Affairs on cross-functional product/project teams and provide regulatory advice.
• Apply organisational understanding and awareness in decision-making.
• Utilise effective communication and influencing skills to develop key relationships with internal/external contacts.

Essential Knowledge:

• Knowledge of the consumer healthcare environment and product development.
• Hands-on experience with regulatory requirements and registration activities for medicines in the EU/EMEA.
• Understanding of regulatory frameworks and external environments, with the ability to apply these to regulatory solutions throughout the product lifecycle.
• Solid understanding of regulatory, medical, safety, and quality requirements in relevant markets.
• Familiarity with processes and departments within a healthcare company.

Core Competencies:

• Excellent communication skills, capable of articulating concepts clearly both verbally and in writing, especially when simplifying complex regulatory or technical issues.
• Strong interpersonal skills; able to build effective personal networks internally and externally.
• Collaborative with a strong sense of ownership, accountability, and recognition for delivering results.
• Strong organisational and time management skills, with the ability to work under pressure.
• Ability to work effectively in a multi-cultural, highly matrixed organisation.
• Proficiency in English.