CuraTeQ Biologics Pvt. Ltd., Hyderabad Regulatory Sciences is hiring for multiple openings in Regulatory Sciences and Regulatory Affairs functions.
Position 1: Regulatory Sciences
Job description: The role involves content writing for briefing books, CMC sections, similarity assessments, etc. This would be a good opportunity for candidates who would like to move from wet lab to scientific content writing.
Qualification and experience: Candidates must have PhD in protein sciences or biotech engineering with 1-3 years biotech industry experience in either process development or analytical development functions.
Excellent english written and oral communication skills with basic level of scientific understanding of biotherapeutic and/or biosimilar product development is essential.
Position 2: Regulatory Affairs
Job description: The role involves dossier filing activities in various geographical regions
Qualification and experience: Candidates must have B. Tech in Biotech or B. Pharma qualifications with the following experience –
For emerging markets: 7-8 years’ experience in LatAm, MENA, Russia, APAC
eCTD Publisher: 3-5 years’ experience for EU or US
India: 3-5 years’ experience of Indian Submissions to CDSCO and DCA markets.
USA: 4-8 years’ experience.