This role is in the Regulatory team at AGI. This role will be responsible to support the regulatory team to manage all regulatory activities for the products assigned.

Responsibilities

• Review, update and ensure accuracy of the data on the Regulatory database on a real time basis to reflect latest Regulatory status.
• Liaise with various stakeholders within Aspen and manufacturing sites to support on all regulatory related matters. (For e.g., gather and provide documents required for regulatory submission in a specific country to ensure amendment to registered details, gather and provide documents required for submission of product license renewals in a specific country, gather specific Intel to support regulatory assessments).
• Support Supply Chain or other streams to gather Regulatory Intel for supply related items
• Ensure proactive and effective communication with the Aspen Project team regarding the regulatory status in all markets for assigned projects (for e.g. communication of regulatory changes for a project related to change of site of finished manufacture of a specific product)
• Assist in responding to regulatory questions, liaising with the Quality Team and manufacturing site as required, applying a critical thinking and problem-solving approach to queries received for timely approvals.
• Raise change controls for changes which have an impact to registered details, where applicable, under guidance from supervisor.
• Seek for and drive process improvement within the Regulatory team and Cross-stream with support from manager.
• Proactively identify any risks or issues and propose alternate solutions to mitigate risks
• To use information and experience to drive effective regulatory strategies (i.e. good communication, critical thinking, having the ability to understand the overall picture)

Requirements 

• Bachelors or Post Graduate degree in Chemistry, Pharmacy or equivalent degree
• In working within Regulatory/Quality or similar environment for 1 year is a plus 
• Clear & effective communication written & verbal
• Attention to detail
• Demonstrates strong planning, organizational & time management skills.
• Basic to Intermediate knowledge of regulatory requirements in EU & ROW markets.
• Ability to proactively identify risk & escalate to supervisor.

What's in it for You?

 We have established a reputable business in just over a decade and as we continue to grow we remain committed to your personal & professional development. You will be entering a challenging & rewarding environment and a culture where courage, learning, intrapreneurship, fun and wellbeing are central. AGI is proud to offer a competitive total rewards system that continue to make us a desirable workplace.