Regulatory Affairs Specialist

This is a fully remote position, open to applicants in India.

📋 Description

• Develop and execute regulatory strategies for medicinal products throughout their entire lifecycle.

• Prepare and manage regulatory submissions independently, including new marketing authorization applications, variations, renewals, and responses to inquiries from regulatory authorities.

• Compile, review, and coordinate regulatory dossiers in accordance with UK and EU regulatory standards.

• Write and review technical regulatory documentation, such as Module 3 sections, Quality Overall Summaries (QOS), packaging texts, Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and labeling documents.

• Provide regulatory guidance and technical expertise to clients and internal project teams.

• Act as the primary regulatory contact for clients and communicate directly with regulatory authorities.

• Monitor and evaluate changes in regulations, advising clients on potential impacts to their products and operations.

• Coordinate and review technical documentation to ensure adherence to regulatory standards.

• Prepare and review user testing readability reports.

• Document, track, and maintain records of regulatory submissions and approvals.

• Support project teams by ensuring regulatory requirements are integrated into project planning and execution.

• Review work conducted by Regulatory Affairs Associates while providing mentoring, coaching, and technical guidance.

• Contribute to systems management and administrative activities related to regulatory operations.

• Deliver high-quality regulatory consultancy services while fostering strong client relationships.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or a related scientific field.

• At least 5 years of experience in Regulatory Affairs within the pharmaceutical sector.

• Strong familiarity with UK regulatory requirements and procedures.

• Demonstrated experience in managing regulatory submissions and lifecycle maintenance activities for medicinal products.

• Experience serving as the primary regulatory contact for clients and health authorities.

• Comprehensive knowledge of UK and EU regulatory frameworks and authorities.

• Strong expertise in the preparation and management of regulatory dossiers.

• Experience in writing and reviewing regulatory and technical documents.

• Solid understanding of medicinal product lifecycle management.

• Excellent analytical, organizational, and problem-solving abilities.

• Strong verbal and written communication skills.

• Capability to manage multiple projects and deadlines in a fast-paced environment.

• Fluent in English (both written and spoken).

• Client-focused mindset.

• Exceptional attention to detail.

• Strong stakeholder management skills.

• Ability to work both independently and collaboratively.

• Proactive, organized, and solution-oriented approach.

• Commitment to quality and continuous improvement.

🏝️ Benefits

• Opportunity to have a significant impact on global healthcare.

• Career advancement opportunities.

• Collaborate with an innovative, forward-thinking global team.

• Engaging and purpose-driven work.

• Remote work arrangement.