Regulatory Compliance Specialist

Position Summary:

This position is responsible for supporting tasks and projects related to management of Regulatory Compliance and new product submissions at Apotech. These activities include QA/Compliance support for worldwide submissions of new drug applications and post approval changes, change control support, manufacturing support and manufacturing license maintenance.

Roles and Responsibilities: 
• Point of Contact to request, source and provide relevant regulatory documentation (e.g. SOPs, Technical Reports, Deviations, Quality Agreements) to support miscellaneous regulatory requests such as paper-based inspections (e.g. Taiwan, Japan etc).

• In collaboration with Regulatory Management, ensure maintenance of the commercial and clinical manufacturers licenses.

• Notarization and legalization management.

• In collaboration with Regulatory Management, works on completing country specific registration, re-registration, accreditation requests.

• Co-ordinate SMEs for reviews of new product and post approval variations submissions to ensure that the JSI sections are accurate and consistent across all products.

• Work with the Regulatory Manager to ensure Regulatory Playbook is maintained and updated in line with current product workflows.

• In collaboration with Regulatory Management, coordinating the Change Summaries for submission in the product Annual Reports, as required.

• Familiarization with license content and license sections in eCTD viewer and work with both the QPs and Regulatory Manager to ensure transparency of information and escalation information is shared.

• Regulatory support for routine manufacturing / quality operations.

• Knowledgeable on regulatory systems such as ERIS, RIACS, GRAIL, RIMDocs, eCTD, etc

Key Competencies Required:
• Collaboration and team work.
• Problem solving and attention to detail.
• Customer focused.
• Clear communication skills.
• Adaptable and flexible.