Regulatory Affairs Senior Associate

Viatris

Key responsibilities for this role include:

• Support the local regulatory team in the development of regulatory strategies to support the registration of new products, line extensions, major variations, and lifecycle management.

• Develop strong partnerships with in-country and above country teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.

• Responsible for enhancing relationships with key external agencies (Egyptian Drug authority EDA). Manage the EDA interface throughout the development and lifecycle of a product.

• Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP s and systems are followed.

• Ensure a submission planning and forecasting tool is utilized to update timelines, when necessary, communicate changes to relevant partners.

• Capable of authoring some local submission components in relevant databases.

• Ensure submission packages are reviewed against local CMC requirements for consistency and completeness.

• Liaise with the manufacturing sites for obtaining supporting documents as needed.

• Participate in local and regional regulatory initiatives promoting a culture aligned with Viatris values and which supports compliance, innovation and talent development and retention.

• Maintain compliance with the regulatory systems, processes and procedures.