Regulatory Affairs Specialist

The department is responsible for the regulatory impact of all the product transfers with external companies. In this position the contractor is responsible for the RA strategy and also look after the process. The worker has contacts with local authorities and stakeholders like supply chain. In this case the contractor will work on the project of a joint venture which is ended and all the packaging related activities are now transferred from Lyon to Netherlands.

ROLE DESCRIPTION

The EMEA Regulatory Integration Coordinator role reports to the Regulatory Integration Lead (RIL) EMEA who is responsible for adequate planning and resourcing of regulatory work to maintain compliance and continuity of supply from an end to end cross divisional perspective within the Europe, Middle East and Africa region.

Our organisation is planning for the dissolution of one of thier Joint Ventures. The Regulatory Integration Coordinator will partner with the RIL to ensure the Legal Entity Integration changes and MA transfers within scope of this project are planned, managed and executed timely and accurately, issues are identified and resolved, and opportunities for improvement are pursued. Scope of this project is EU regulated countries

PRIMARY ACTIVITIES

- Working closely with RIL and countries to collect and analyse regulatory intelligence that is required to develop a regulatory strategy for a specific project and perform impact analysis on this data to ensure the information is available for optimal planning and execution of the projects.
- Under direction of the RIL, support the regulatory strategy, planning, execution and tracking of changes to include but not limited to: working with cross divisional groups (eg regulatory affairs, regulatory operations, Packaging sites and artwork teams, CMC, Supply Chain) to identify regulatory risks and enable earliest possible approval.
- Work closely with cross-functional teams to provide country-level status and reporting. Secure continuous follow-up & interaction with Countries' RA and/or RAE on execution status and on tracking milestones' achievements of the project plans.

QUALIFICATIONS

- BS/MS preferably in a science related to medicines with at least 5 years of working experience with a regulatory affairs function in the pharmaceutical industry.
- Demonstrated ability to work in a global regulatory environment, and with workflows associated with the preparation and submission of product filings, at the HQ and country level.
- Skilled in the management of complex and time-urgent project plans.
- Technically proficient in the use of tools to develop plans, manipulate spreadsheets, create reports.
- Demonstrated ability to collaborate and communicate across cultures.
- Demonstrated problem-solving ability, effective and timely decision-making, and negotiating skills.
- Ability to focus on customers, and has the candor, courage and willingness to listen and speak up.