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Senior Regulatory Affairs Specialist
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Senior Regulatory Affairs Specialist
Location: Reading, Berkshire, United Kingdom
Work Arrangement: Hybrid
Industry: Consumer Healthcare / Pharmaceuticals
Role Overview
A leading global healthcare organization is seeking a Senior Regulatory Affairs Specialist to support regulatory activities across EMEA medicinal products. This role will focus on maintaining existing marketing authorizations, managing regulatory submissions and lifecycle activities, and ensuring ongoing compliance with applicable European and local requirements.
The position will work closely with Regulatory Affairs, Quality, Safety, Clinical, and other cross-functional teams within a highly matrixed international environment.
Key Responsibilities
- Prepare and submit regulatory applications in accordance with applicable EU requirements, including MRP and DCP procedures.
- Manage post-approval regulatory activities, including variations, renewals, safety updates, and other lifecycle management submissions.
- Coordinate responses to Health Authority questions in collaboration with relevant internal functions.
- Monitor regulatory authority review processes and maintain effective communication with Health Authorities throughout the submission lifecycle.
- Evaluate regulatory requirements relating to quality, preclinical, and clinical information.
- Plan, prioritize, and monitor regulatory projects against established timelines and deliverables.
- Maintain a strong understanding of the regulatory environment and supporting data requirements.
- Ensure assigned products remain compliant with applicable regulatory, quality, and local requirements.
- Maintain accurate regulatory information and support the effective use of enterprise Regulatory systems.
- Identify opportunities to improve local regulatory processes and support implementation of resulting changes.
- Support internal and external audits and regulatory inspections.
- Collaborate with cross-functional teams to address regulatory, business, and other sensitive issues.
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Requirements
- Bachelor's degree or higher in a relevant discipline.
- 6+ years of relevant regulatory affairs experience, ideally involving non-prescription medicinal products and EU regulatory procedures.
- Proven experience with EU MRP/DCP procedures.
- Strong experience in non-CMC lifecycle management and safety updates.
- Excellent attention to detail and strong organizational skills.
- Excellent written and verbal communication skills, including the ability to simplify complex regulatory or technical topics.
- Strong interpersonal skills with the ability to build effective relationships across internal and external stakeholders.
- Demonstrated ownership, accountability, and a results-oriented approach.
- Strong time management skills and the ability to manage multiple priorities under pressure.
- Experience working effectively within multicultural and highly matrixed organizations.
- Fluency in English.
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Preferred Experience
- Knowledge of the consumer healthcare environment and product development.
- Understanding of healthcare company functions, processes, and cross-functional operating models.
- Experience working within regulated healthcare, pharmaceutical, or consumer health environments.
What’s Offered
- Competitive benefits package.
- Paid holidays and vacation.
- Volunteer time and additional employee programs.
- Learning and professional development opportunities.
- Employee resource groups.
- Hybrid working environment.
- Opportunity to work within a global, cross-functional regulatory organization.
Industry: Consumer Healthcare / Pharmaceuticals
Function: Regulatory Affairs
Seniority: Senior Specialist
Location: Reading, Berkshire, UK
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