Job Description
Cobel Zist Darou (affiliated with Cobel Darou); a new upcoming manufacturing company in Iran has an open position for an Authorized Person. The "Responsible Pharmacist" or an "Authorized Person" is responsible for the entire drug approval and is responsible for all the technical aspect of the particular drug. The following are some of the responsibilities of this individual and is not exclusive. • Compile under supervision regulatory documents for submission • Participate as an active team member of project teams as required • Compile and prepare responses to regulatory authorities questions • Maintain regulatory files in a format consistent with requirements • Maintain awareness of regulatory requirements • Technical systems skills (e.g. word processing, spreadsheets, databases, online research) • Proofreading and editing skills • Ability to contribute to multiple projects from a regulatory affairs perspective • Ability to multitask and prioritize Note: Please avoid any phone calls! We will NOT consider any candidates who will contact the company directly. Thank you!
Requirements
• Individuals who posses Phram D. degree. • Individuals who have minimum of two years hands-on experiences in the Iranian Pharmaceutical production. • Complete understanding of cGMP and injectable pharmaceutical production. • Good understanding of the Iranian drug approval submission process. • Strong communication skills to facilitate discussions and negotiations with internal business partners and regulators. • Profession in writing and speaking English. Note: Individuals who posses more than 3 years of hands-on pharmaceutical production will be highly considered
Employment Type
- Full Time
Seniority
Details
Employment type
- Full Time
Educations
Seniority
