Lead - Regulatory Affairs - Biosimilars/Biologics/Biopharmaceuticals

Reporting into Head Regulatory (CMC), your responsibilites would include the following:

- Ensure your team prepares, coordinates and submits in line with the provided requirements the applications for Variations and Renewals to authorities (regulatory agencies) within agreed timelines and in accordance with agency requirements

- Manage and prioritize your team's workload in accordance with the expectations of the associated Business Unit and/or Market Unit(s)

- Oversee the preparation and filing of high-quality submissions to regulatory authorities.

- Ensure all applications are filed in accordance with predetermined timelines.

- Provide expert regulatory strategy/guidance to your team in alignment with the associated Business Unit and/or Market Unit

- Develop staff to continuously improve the performance of your team.

- Maintain regular contact with peer(s) in the associated Business Unit and/or Market Unit(s)

- Aign with other Team Leads in the Shared Service Centre to ensure consistency of approach and methodology across delivery teams.

- Ensure day-to-day delivery of expected services at agreed upon service levels and budgeted cost.

QUALIFICATION AND WORK EXPERIENCE :

- Bachelor's degree in Life Sciences or related scientific field.

- Certificate in Regulatory Affairs beneficial

- 10 years of experience in Biologics, biopharmaceutical world.

- Any experience in biosimilars a plus, from which at least 5 years in managing teams

- Extensive experience in Regulatory Affairs

- Fluent in English (written and spoken)

- In-depth knowledge of Regulatory Affairs in 1 or more geographies (i.e., Europe, NAMRegion)