Regulatory Affairs Project Manager - Submissions

Overall Job Objectives

The Regulatory Affairs (RA) Project Manager is responsible for coordinating and overseeing regulatory submission activities across Europe and CIS markets, ensuring that regulatory projects, submissions, and registrations are delivered on time and in compliance with applicable regulations. Reporting to the Head of Regulatory Affairs Europe, the role acts as a key liaison between Regulatory Affairs, Pharmacovigilance, Compliance, Quality, and other business functions. Key responsibilities include managing regulatory submission plans and trackers, coordinating cross-functional projects, monitoring regulatory intelligence and changing requirements, supporting regulatory strategy development, mitigating regulatory risks, and ensuring timely responses to health authority requests. The role also supports quality and compliance activities, develops regulatory processes and training, generates KPI and management reports, and helps ensure the successful introduction and maintenance of products across multiple markets. Overall, the position combines project management, regulatory operations, stakeholder management, compliance oversight, and regulatory strategy support to ensure effective regulatory execution across the region.

Responsibilities

Management and coordination of regulatory operations for regulatory submission team with decentralised set up

• Representing regulatory submission function in the projects related to the operational changes, technical projects or the projects driven by PV department
• Compile country specific regulatory intelligence from Regulatory Affairs Managers responsible for regulatory submission activities in all EU CIS territories and provide the consolidated intel on the Regulatory Plan to the stakeholders from other departments - Pharmacovigilance, Regulatory Compliance, Global Regulatory
• Provide support in respect to registration strategy (assist in development of regulatory strategy) as well as monitoring the impact of changing regulatory environment on submission strategies
• Introduction of the new projects to regulatory submission team
• Communicate of the project status to the local affiliates in scope of the project via regular meetings
• Coordinate with regulatory submission team the planned submissions ensuring that expectations and objectives are shared on time, documentation required for the submission provided and submission timelines are met
• Plan and monitor of submission date per market ensuring that registration deadlines are met, track submission progress through efficient communication to relevant Aspen stakeholders and Regulatory Service Providers (RSPs) and communicate any change in status or delays
• Proactively inform the Head of RA (Europe) and other involved business units regarding all identified risks related to the planned MA applications
• Coordinate with Regulatory Compliance the preparation of responses to Request for Information (RFI) received from Health Authorities to achieve the harmonised registered data across the countries
• Manage the Commitment Tracker
• Support / Coordinate the data needed to make all required registration fees in a timely manner
• Liaise with other departments to support the timely introduction of new products into markets
• Assess the impact on existing registered documentation when new regulatory requirements are issued
• Perform assigned tasks to the highest standard and in accordance with established internal timelines and guidelines.
• Ensure information exchange and periodic reporting to the Head of RA (Europe) - updating and maintaining regulatory submission and RFI tracker on a weekly basis
• Monitor planned approval timelines and if necessary, intervene in order to facilitate approval and minimise registration delays
• Raise change controls and provide regulatory assessment, strategy and regulatory impact assessment for change controls
• Manage the regulatory intelligence updates for the region
• Ensure all activities are within the framework of the Aspen QMS
• Provide regulatory input for the Annual PQR and PSUR / PBER
• Always perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines
• Generate Standard Operating Procedures and implement where relevant to the regulatory function
• Implement regulatory trainings of all regulatory personnel
• Ensure that accurate records are kept and maintained in a secure manner as per Good Documentation Practice; ensure proper data management and archiving
• Generate KPI reports
• Compile update for Quality Systems Management Review (QSMR) meetings
• Monitoring and reporting on regular basis the status of regulatory submissions across the region
• Any other duties as assigned by Senior Management
• High level education such as BSc, MSc, PhD or Pharmacist in Life sciences or related area
• At least 3-5 years in a similar role in Regulatory in the pharmaceutical industry
• Proficient English skills

Person Profile

• Results and performance driven - deliver results that meet or exceed expectations
• Accountability and ownership - deciding and initiating actions
• Sense of urgency - responding to issues and opportunities in a timely manner
• Intellectual curiosity - willing to suggest and try new ideas
• Positive and pro-active approach to business tasks
• Excellent interpersonal and communications skills.
• A solutions provider with strong multi-tasking abilities
• Manage evolving deadlines effectively with regular feedback and updates
• Enthusiasm and Drive to take ownership