Regulatory Affairs Officer

Kelix bio (Malta) Ltd

Job Ref: KMP-92813

Kelix bio (Malta) Ltd Logo

Basis

Full-Time

Apply by

01-Sep-2024

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Kelix bio is a reliable, specialized supplier of liquid and lyophilised sterile pharmaceuticals for antineoplastic use in humans. Through our products we help patients achieve the highest quality standard of life possible. We create a strong presence in both local and international markets based on our reputation for service quality, value-added products and reliability of supply.

Due to the expansion of our operations, we require for immediate employment a Regulatory Affairs Officer to join our team. 

Responsibilities:

  • To help the organization implement regulatory strategies, which can be local, state, national or international.

  • Ensure that the company's products comply with the regulations of the regions where they are going to be distributed.

  • To support the development of product registration submissions and variations.

  • Prepare submissions of licence variations and renewals to strict deadlines

  • Monitor and set timelines for licence variations and renewal approvals.

  • Take part in the development of marketing concepts and approve packaging and advertising before a product's release.

  • To execute specialized projects and develop solutions.

  • To assist with the interpretations of evolving regulations, standards and guidance related to product registration and associated variations.


Requirements:

  • A Bachelor’s Degree, ideally in a scientific or technical discipline.

  • Minimum 2 years of experience in regulatory affairs in the pharmaceutical industry.

  • Knowledge / experience with regulatory requirements for other regions also desirable.

  • Working knowledge of GMP, and GDP regulations as well as an understanding of the pharmaceutical product life cycle. 

  • Good verbal and written communication skills.


Kelix bio (Malta) Ltd - KMP-92813