Job Ref #: AGIG07
Industry: Pharmaceutical And Medical/Healthcare
Job Type: Contract
Positions Available: 1
This role is in the Regulatory team at AGI. You will be responsible to support the regulatory team to manage all regulatory activities for the products assigned.
Job Description
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 150 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 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 700 million packs of medicine worldwide since inception.
Overall Job Objectives
This role is in the Regulatory team at AGI. You will be responsible to support the regulatory team to manage all regulatory activities for the products assigned.
Responsibilities
- 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).
- Review, update and ensure accuracy of the data on the Regulatory database on a real time basis to reflect latest Regulatory status.
- 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)
Job Requirements
- Bachelors or Post Graduate degree in Chemistry, Pharmacy or equivalent degree
- Takes initiative and is proactive
- Clear & effective communication written & verbal
- Attention to details
- Analytical & Problem-solving skills
What's in it for You?
This position is part of our Graduate Program. You will receive a one-year contract to work in an international environment at Aspen Global Incorporated, one of the largest companies in Mauritius and a proud Great Place to Work. 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.