Regulatory Affairs Submissions Manager

Overview

The role focuses on leading the Regulatory Affairs (RA) International Submissions Team, managing MRP/DCP, CP and global submissions to ensure timely, compliant, and high-quality regulatory documentation. It involves driving regulatory strategies, maintaining Marketing Authorisations, and leading proactive issue management through effective cross-department collaboration.

Core Responsibilities

• Lead and coordinate all submissions performed by the RA International Submissions Team including MAAs, variations, renewals, notifications, and scientific advice procedures.
• Develop submission strategies, evaluate regulatory risks, and update stakeholders on changing regulatory requirements.
• Prepare, review, and maintain dossiers (eCTD and hard copy) ensuring completeness and compliance while auditing licensor dossiers for conformity with guidelines.
• Manage regulatory documentation and records throughout submission processes.
• Act as the Subject Matter Expert for IDMP and SPOR data compliance, leading preparation and quality control of regulatory data and supporting data governance within the department.
• Oversee Marketing Authorisation lifecycle activities such as renewals, variations, and impact assessments to maintain compliance and currency.
• Collaborate extensively with internal departments, affiliates, external partners, and Global IP on global registrations, product launches, and licensing evaluations.
• Coach and develop Regulatory Affairs Officers at varying levels, promoting continuous learning, capability building, and innovation.
• Ensure compliance with all relevant legislation, guidelines, and SOPs, while contributing to process and policy improvements.

Requirements

• Bachelor's degree in life sciences such as Chemistry, Biology, or Pharmacy.
• A minimum of 4 to 5 years' experience in a regulatory affairs capacity within pharmaceuticals, preferably with supervisory or management responsibilities.
• In-depth knowledge of EU dossier requirements, registration processes, and nuanced national regulations within the EU and other markets.
• Familiarity with specialized RA IT systems such as eCTD submission platforms, regulatory databases, and change control management tools.

Additional Information

• Strong leadership capabilities to recruit, mentor, and evaluate regulatory staff.
• Ability to grasp evolving regulatory landscapes and impart training to internal teams.
• Adeptness in cross-functional collaboration to support approvals and launch timelines.
• Performance of other duties as assigned by senior leadership to support departmental goals and continuous improvement.