Alembic Pharmaceuticals Job vacancy – Submit Resume

Role & responsibilities

Support pre-clinical, clinical activities and work closely with injectable Formulation and development team (FnD) team for drug delivery product (e. g. lipid and/or nanoparticle) and complex injectable, peptide as essential.

Preparation of protocol request form based on literature review and evaluation of previously conducted study data

Review of study protocol, ICF, CRF and other study related documents in compliance to ICH-GCP and applicable regulatory requirements

Monitoring of BA/BE studies in healthy volunteers and PK studies in patients

Co-ordination with F&D and CRO for submission of study protocol to regulatory authority for BE-NOC application and replying queries, if any.

Coordination with CROs and support QA team for study specific audits to ensure the studies are conducted appropriately and comply with regulatory requirements

Review and finalization of protocols, study reports and related documents to ensure accuracy and compliance with regulatory requirements prior to submission

Coordinate and manage bioequivalence studies with pharmacokinetic and clinical endpoints to achieve desired ANDA submissions

Assist in CRO site selection through competitive bidding and preferred provider agreements

Evaluation of the selected CROs and working with the Legal team to create contracts and individual project agreements (IPAs) for studies

Coordinate for management of Investigational Products (IPs) to be used for clinical study.

Preferred candidate profile

• MS/M.Pharm/ Ph. D. in pharmacy (Specialization in Pharmaceutics/ Pre- Clinical activities /F&D) with relevant Experience of 3-4 Years.

Interested & relevant candidates may share their updated CV on msnt@alembic.co.inwith the subject line as “Complex Injectable”.