Global Scientific & Regulatory Affairs Senior Officer

Posted 13 Days Ago
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Marousi, GRC
In-Office
Senior level
Biotech • Pharmaceutical • Manufacturing
The Role
Conduct safety risk assessments and genotoxicity evaluations for drugs and chemicals, coordinate with regulatory authorities, prepare toxicological responses, and compile non-clinical and clinical dossier overviews. The role requires toxicology expertise, experience with in-vitro and animal toxicity studies, analytical and clinical chemistry knowledge, regulatory guideline knowledge, strong English communication, and effective prioritization and time management.
Summary Generated by Built In

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 Required

  • Degree in toxicology or a related field such as biology, biochemistry, or pharmacology
  • Postgraduate degree or experience in toxicology
  • Experience with in-vitro toxicity studies
  • Experience with animal toxicity studies
  • Experience with analytical and clinical chemistry techniques
  • Excellent written and spoken English communication skills
  • Computer literacy
  • Knowledge of relevant regulatory guidelines
  • Ability to multitask, prioritize work, manage time, and meet deadlines
  • Strong interpersonal skills
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The Company
HQ: Amstelveen
1,600 Employees
Year Founded: 1969

What We Do

Pharmathen is a research-centered, pharmaceutical company focused on developing and marketing innovative generic products and complex drug delivery technologies, aiming to provide Life Cycle Management solutions.

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