Assistant Manager Regulatory Affairs

About Role:

The organisation operates as a virtual generics company which holds its own marketing authorisations (primarily oral dosage forms) within the United Kingdom/United Arab Emirates and a manufacturing/importation authorisation.

Key Pharmaceuticals is part of the Bestway Healthcare Group, a vertically integrated business.

Requirements:

• Minimum 7+ years experience within the pharmaceutical industry
• R & D and EU regulatory background preferred
• Proven history of CMC, dossier compilation and submission to UK and EU.
• Understanding of pharmacovigilance and compliance requirement to marketing authorisation is preferred
• Demonstratable ability to learn independently
• Problem solving and proactive prevention through escalation
• IT literacy
• Good communication and organisation skills
• Willingness to bring new ideas to the table and drive continuous improvement as part of the companys quality culture

Salary and benefits:

• Competitive salary
• Monday – Friday 9 hours a day
• 31 days annual leave per annum

Key Responsibilities:

• Duties shall change as the organisation grows
• Engage in routine interdisciplinary team meetings
• Prepare and submit new application dossiers for UK, EU, and other global regulatory regions
• Assist in the drafting, review, and finalization of regulatory technical documents
• Conduct artwork reviews to ensure compliance with regulatory and branding standards
• Prepare and review text versions and Impack files for product labels and leaflets
• Compile and publish submissions using eCTD format, ensuring accuracy and completeness
• Coordinate with Quality Assurance (QA) and Pharmacovigilance (PV) teams to support daily cross-functional activities
• Maintain and update regulatory databases, trackers, and documentation records
• Manage and monitor R&D projects in collaboration with Contract Development and Manufacturing Organizations (CDMOs), ensuring timely updates, milestone tracking, and issue resolution.
• Conduct comprehensive dossier evaluations and due diligence for potential in-licensing opportunities, assessing regulatory feasibility and compliance risks.
• Serve as the primary point of contact for regulatory authorities, coordinating and responding to queries related to new Marketing Authorization (MA) submissions.
• Prepare and submit MA applications with precision, ensuring accurate and timely responses to Requests for Information (RFIs) within stringent deadlines.