Regulatory Affairs Submissions Manager

The primary objective of this role is to lead the RA International Submissions Team and oversee all MRP/DCP and global regulatory submissions, ensuring compliant, high-quality documentation, and timely delivery. The role also drives regulatory strategy, maintains compliant Marketing Authorisations, and ensures timely product approvals through strong cross‑functional collaboration and proactive risk management. As the department’s IDMP SME, the role ensures high‑quality SPOR/IDMP data, supports data‑governance processes, and maintains compliance with evolving regulatory data standards. Additionally, it aims to strengthen departmental capability by coaching and developing the Regulatory Affairs team, fostering continuous improvement, and building robust regulatory and data‑management expertise across the department. nternational Submissions Team Management and Submission Strategy: Manage and coordinate all regulatory submissions handled by the RA International Submissions Team, ensuring compliance, accuracy, and on‑time delivery. Oversee MRP/DCP, CP and national submissions, including MAAs, variations, renewals, notifications, and scientific advice procedures. Develop and support regulatory strategies, assess regulatory risks, and communicate impact of evolving requirements to relevant stakeholders. Ensure timely, high‑quality responses to Health Authority queries and proactively manage issues that may affect approval timelines. Dossier Management and Data Management: Compile and review EU and national submission dossiers (eCTD/hard copy), ensuring completeness and compliance with regulatory standards. Identify and resolve gaps in dossier content and anticipate potential Health Authority concerns. Audit licensor dossiers for acceptability and alignment with EU and national guidelines. Maintain accurate regulatory documentation, databases, and records throughout the submission lifecycle. IDMP SME Responsibilities: Serve as the department’s IDMP Subject Matter Expert, ensuring compliance with ISO IDMP and EMA SPOR data requirements. Lead the preparation, review, and maintenance of high‑quality IDMP/SPOR data across internal systems and regulatory submissions. Support data governance processes and collaborate with cross‑functional teams to ensure data accuracy, consistency, and readiness for regulatory use. Monitor evolving IDMP requirements, assess impacts, and provide training and guidance to internal teams. Marketing Authorisation Maintenance: Manage lifecycle activities including renewals, variations, change controls, and regulatory impact assessments. Ensure Marketing Authorisations remain current, compliant, and aligned with new regulatory requirements. Support PQRs, PSURs/PBRERs, and other ongoing compliance obligations. Communicate submission plans, approvals, and timelines to relevant functions. Cross‑Functional & External Collaboration: Work closely with internal departments, affiliates, Global IP, and external partners to support global registrations and product launches. Contribute to regulatory aspects of in‑licensing evaluations and cross‑functional project teams. Coordinate national phase activities, including translations and artwork updates, to support timely approvals. Leadership & Team Development: Manage, coach, and develop Regulatory Affairs Officers at varying experience levels. Recruit, train, and evaluate staff performance while fostering a culture of continuous improvement and innovation. Provide regulatory training, share knowledge, and support team multiskilling and capability building. Regulatory Compliance & Good Practice: Ensure all activities comply with legislation, guidelines, and internal SOPs. Monitor regulatory changes and ensure timely implementation within the department. Contribute to the development and improvement of regulatory policies, processes, and SOPs. Personal and Departmental Development: Identify development needs and implement learning solutions aligned with personal and team development plans. Promote best practices and support ongoing skill development across the department. Perform additional duties as assigned by senior management. Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree Min 4-5 year experience in a regulatory affairs environment in the pharmaceutical industry preferably with management/supervisory experience Detailed knowledge of EU current registration requirements for dossier preparation and procedure running Solid knowledge of specific national requirements in EU and other regions Knowledge of IT tools specific for in RA and pharmaceutical sector (e.g. eCTD, databases, change control management etc.) #LD