Regulatory Affairs Associate - Compliance jobs in Malta - September 2021
JOB TYPE: Full Time JOB LEVEL: Experienced (3 years +)
CATEGORY:
Compliance
EMPLOYER INDUSTRY: Pharmaceuticals
Teva Pharmaceutical Industries Ltd. is looking to recruit a Regulatory Affairs Associate to join their team on a full-time basis. 

The Position:

This position reports to the Team Lead Regulatory Affairs and forms part of the Regulatory Affairs team, supporting the manufacturing site. This position is mainly responsible for supporting the company to obtain and maintain marketing authorisations for EU and Growth Markets, by actively participating in the change control system, by providing regulatory expertise and support in order to avoid any production disruption while maintaining compliance. The main activities include but are not limited to keeping the dossiers (Module 3 and QoS) fully up to date in compliance with the latest regulatory requirements, preparing the necessary documents in support of dossier and variations submissions, and responding to queries from Competent Authorities during Marketing Authorisation or Variation procedures.

The Applicant:
The position calls for a person having:
  • Degree Level of Education in Pharmaceutical Technology/Pharmacy or Chemistry/Biology and/or at least 5 years experience in a related field within the pharmaceutical industry;
  • Good technical, verbal, and written communication skills and ability to work effectively with internal/external stakeholders as may be required;
  • Customer-oriented mindset;
  • Pro-active and result-oriented;
  • Knowledge of the EU regulatory framework would be considered as an asset;
  • Very good computer skills, excellent organizational skills, must have an eye for detail and a methodical approach to work, must be able to work under pressure and on own initiative.

Teva Pharmaceutical Industries Ltd.:
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In speciality medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and speciality capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2017 were $22.4 billion. 

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