Junior Regulatory Associate

Aspen Global Incorporated (AGI) is the Mauritian subsidiary of Aspen Pharmacare Holdings Limited and was established in 2008. It is a global specialty and branded multinational pharmaceutical company with a presence in both emerging and developed markets. AGI has been the launchpad of the Group’s Global expansion. We are very proud that from Mauritius we improve the health of patients in more than 100 countries through our high quality, affordable products. Our key business segments are Manufacturing, Supply Chain and Commercial. Our global Brands comprises sterile Focus Brands that include Anaesthetics, Oncology and Thrombosis products. Many of the Aspen supplied medicines are lifesaving or medically critical. We employ over 200 people of which around 75% are Mauritian. We are one of Mauritius' largest companies with a turnover in excess of 40 billion Mauritian Rupees. We have a diverse workforce with over 20 different nationalities. We are liaising with over 60 different subsidiaries worldwide every day. We have supplied more than 1.3 billion packs of medicine worldwide since inception. Overall Job Objectives 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)