Job Description
About us
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 is 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.
