Senior Executive
Mumbai
Job description
Education
PG: MS/M.Sc (Science) in Any Specialization, M. Pharma in Any Specialization
Required Experience : - 3 to 8 years (Experience in US market preferred)
Role & responsibilities
Experience in US submissions.
Dossier review and compilation of ANDAs for the US market.
Post approval for US market.
Document review i.e. specifications, batch records, method validation documents, stability data, container closure system, DMF review.
Hands on Electronic operation (eCTD & SPL).
Labelling related activities.
Preferred candidate profile
Team Handling Experience is preferred.
Experience in US submissions.
Knowledge of CMC Documentation required for Submissions.
Knowledge & Experience of Pharma ready Software.
Role: Legal & Regulatory - Other
Industry Type: Pharmaceutical & Life Sciences
Department: Legal & Regulatory
Employment Type: Full Time, Permanent
Role Category: Legal & Regulatory - Other
Interested candidate can share their updated resume on [email protected]