· Supporting the Pharma commercial teams on topics including regulatory, legal compliance, quality and product safety.
· Document preparation, handling product registration applications ensuring drugs are legally authorised for the markets intended.
· Completion of technical and regulatory information requests from customers within the pharmaceutical industry (questionnaires, supply chain agreements, QAA’s & TA’s).
· Contribute as part of team to maintain APAC document management system to keep product and supplier information up to date.
· Communicate with authorities, clients, suppliers and associates.
· Monitor regulatory legislation, environment, changing landscapes and implications for the organisation.
· Develop and implement internal standards, procedures and work instructions.
· Maintain and administrate regulatory data base and provide regulatory education and advice
· Request product and supplier information directly from manufacturers and indirectly via other internal channels.
· Process Change Control Notifications.
· Creation and ongoing update of product regulatory information in standardized information packs.
· Support of customer, regulatory and 3rd party risk assessments and audits.
· Reporting and documenting customer requests via KPIs.