ZEINCRO, a leading Contract Research Organization which provides full range, high quality services to the pharmaceutical industry is looking to recruit a: Regulatory Affairs / CMC Specialist (RAO/CMC) to join an international team of professionals working on global projects
Purpose of the role:
Regulatory Affairs /CMC specialist is responsible for maintaining the technical dossiers of medicinal products up to date, preparing and submitting variation applications, updating the Products Information texts, performing regulatory review on packaging material and maintaining company’s databases up to date.
Required Skills & Knowledge:
- University Degree in Pharmacy, Chemistry or Life Sciences; post graduate diploma in relevant field will be considered an asset
- Previous experience of at least 2 – 3 years in the Regulatory Affairs and/or CMC
- Profound knowledge and understanding of EU regulatory legislation, guidelines, requirements and procedures
- Experience in development and update of CTD M.3 and implementation of ICH/EMA guidelines in CMC documentation
- Strong critical thinking & ability of data interpretation
- Attention to detail as well as analytical and problem-solving skills
- Advanced communication skills, team orientation, ability to successfully convey messages
- Self-motivated, able to work effectively under pressure independently and within teams in a highly demanding multinational working environment
- Excellent command of French and English languages
- Excellent knowledge of MS Office
Join us for a challenging career!
Zeincro offers a competitive remuneration package, as well as continuous development and career opportunities in an exciting, international and supporting working environment. At Zeincro your career will flourish, as we care in supporting and developing our people.
If you are interested in this job opportunity please send your CV to: firstname.lastname@example.org.