Posted 19 days ago
Global Scientific & Regulatory Affairs Senior Officer
AI Summary
Evaluates toxicological data and studies for pharmaceutical products, conducts safety risk assessments including genotoxicity evaluations, liaises with regulatory authorities, and prepares non-clinical/clinical dossier overviews.
About this role
Founded in 1969, Pharmathen has grown into a leading developer and manufacturer of specialized pharmaceutical products and one of the largest vertically integrated companies in advanced drug delivery technologies. With a strong international presence, we remain committed to improving people’s lives through innovation and access to affordable, high-quality medicines. Today, our products reach patients in more than 90 countries worldwide, supporting better health outcomes every day.
Pharmathen employs more than 1,600 people from over 27 different nationalities, reflecting a diverse and international workforce. Our achievements are driven by strong scientific expertise, high ethical standards, and the dedication of our people, who share a commitment to improving patient lives.
Pharmathen offers a great opportunity for career development and is seeking to recruit a Global Scientific & Regulatory Affairs Senior Officer to join our team at our Metamorfosi premises.
As a Global Scientific & Regulatory Affairs Senior Officer, the ideal candidate will assist and evaluate toxicological data and studies.
Requirements
What you will do:
More particularly:
- Carry out safety risk assessments including genotoxicity evaluations for therapeutic drugs, and various chemicals (small chemicals, peptides, polymers)
- Liaise with regulatory drug authorities in order to prepare toxicological responses and assessments for various therapeutic drug products
- Preparation of dossier overviews (non-clinical and clinical)
The ideal candidate should have:
- A degree in toxicology or in a related field such as biology, biochemistry, pharmacology, and post-graduate degree/experience in toxicology)
- Specific experience with in-vitro, and animal toxicity studies, as well as with analytical/clinical chemistry techniques
Job-Specific Skills:
- Excellent communication in English language (writing & speaking)
- Computer literacy
- Multi-tasking
- Time management
- Ability to prioritize work and meet deadlines
- Strong interpersonal skills
- Excellent knowledge of the relevant guidelines
Benefits
What you'll gain:
- Involvement in a high-caliber, team-oriented and dynamic atmosphere
- Exposure to challenging business issues and practices
- Great opportunity to leverage and develop your business knowledge and skills
Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.
Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.
Skills
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