Global Regulatory Affairs Manager

Om jobbet

For products within defined responsibility, including but not limited to:

- Manage the core and local regulatory dossiers, life cycle management and compilation of

submissions for medicinal products.

- Creation and/or review of regulatory documentation relevant for submission

- Maintain current knowledge base of existing and emerging regulations, standards, or guidance

documents.

- Provide regulatory input to cross functional teams/projects.

- Co-ordinating subsidiaries, partners and consultants on applicable market(s)

- Regulatory project lead when relevant.

- Product Information - creation, revision and translations to local languages.

- Ensure updates of applicable national databases and product monograph websites

- SOP development and maintenance.