Regulatory Affairs Associate

About the Company

An established pharmaceutical company based in London is seeking to expand its Regulatory Affairs team. The role involves working within a collaborative international environment supporting regulatory compliance and submission activities across UK and EU markets.

Role Summary

The Regulatory Affairs Associate will assist in the creation, review, and submission of regulatory documentation for Health Authorities. The position includes handling new applications, managing post-approval updates, maintaining regulatory databases and trackers, and liaising with internal and external parties to ensure ongoing compliance and effective product lifecycle management.

Key Responsibilities

• Assist in preparing and submitting regulatory applications across UK and European jurisdictions.
• Evaluate modifications to existing product licenses and contribute to regulatory strategy development.
• Review documents prepared for submission to Health Authorities for accuracy and compliance.
• Coordinate assigned regulatory tasks to meet project deadlines.
• Maintain comprehensive regulatory trackers and communicate approval statuses to relevant internal stakeholders.
• Support compliance activities related to product licenses and provide guidance to internal teams as needed.
• Ensure marketing authorizations adhere to applicable UK and EU regulations consistently.

Qualifications and Experience

• Bachelor's degree in Chemistry, Pharmacy, Life Sciences, or a related field.
• At least two years' experience in the pharmaceutical sector.
• Familiarity with UK and EU medicinal product regulatory frameworks.
• Practical experience preparing and reviewing regulatory submission documents.
• Knowledgeable about electronic submission procedures, electronic Quality Management Systems (eQMS), and change control processes.
• Excellent communication abilities both written and spoken.
• Strong organizational skills with the capability to manage several priorities simultaneously.
• Demonstrates a collaborative and professional demeanor with a commitment to regulatory compliance standards.

Benefits

• Growth opportunity to advance a career in Regulatory Affairs within a developing pharmaceutical organization.
• Exposure to a wide spectrum of regulatory functions in UK and EU markets.
• Work in a collaborative environment engaging with cross-functional teams.
• Competitive salary paired with an attractive benefits package.
• Availability of hybrid working options.