Junior Regulatory Associate
Aspen Pharma Group
2022/01/24   Mauritius

Job Ref #: AGIJRA004
Industry: Pharmaceutical And Medical/Healthcare
Job Type: Permanent
Positions Available: 0

Aspen Global is hiring! We are on the lookout for a Junior Regulatory Associate in our Regulatory team!

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 Anesthetics, 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.

We are now recruiting for a Junior Quality Associate, who will report into the Manager, Quality.

Objective of the Role        

The Junior Regulatory Associate will be responsible to support the regulatory team to manage all regulatory activities for the products assigned.

Your 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.
  • 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

What You Need To Be Successful In the Role

  • Bachelors or Post Graduate degree in Chemistry, Pharmacy or equivalent degree.
  • Atleast a years working experience within a similar role, or equivalent.
  • Clear & effective communication, both written & verbal.
  • Project Management experience would be a plus.
  • Demonstrates strong planning, organizational & time management skills.

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.

Important notice to Employment Businesses/ Agencies

Aspen will not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the Aspen Global Inc. HR department to obtain prior written authorisation before referring any candidates. Obtaining of prior written authorisation is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Aspen Global Inc. In the absence of written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Aspen Global Inc. Aspen Global Inc. therefore shall not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.