Hello everyone !!
Encube Ethicals are hiring for Regulatory Affairs Department.
Qualification: M.Pharm / M.Sc.
Experience: 2 – 5 years.
Location: Andheri (Marol), Mumbai.
Roles and Responsibilities
· Dossier compilation of ANDA for the US Market.
· Post approval for US Market.
· Document review i.e. specifications, batch record, method validation documents, stability data, container closure system, DMF review.
· Hands-on electronic operation (eCTD and SPL) experience.
· Labelling-related activities.
· Application preparation, submission & follow-up with CDSCOFSA/FDA to get import, export, form 29 and NOCs.
· Etc.
Interested candidates can share their resumes on [email protected]