Glenmark Pharmaceuticals – Regulatory affairs Job OPENINGS 2021

Assistant Manager – Regulatory Affairs

R&D Centre, Taloja

QUALIFICATION M. Pharm/B.Pharm

WORK EXPERIENCE 08 to 9 years

Roles & Responsibilities

• Compilation of ANDA dossier, deficiency

• response to FDA queries in eCTD format Strong review of Technical data required for ANDA compilation and deficiency response submission; Thorough DMF review & complete understanding of ICH guidelines

• and FDA guidances. Strong understanding of CMC, formulation development, Analytical Method Validation requirements and parameters included/stability/Photo stability and Forced degradation, etc Knowledge

• wirt OSD/Liquid Oral/Derma dosage

• forms is essential for this position Drafting of Controlled correspondence to the USFDASupport different stake holders for OSD, Oral liquid dosage forms and Derma by providing regulatory strategies

• Impart training to CFT’s for current FDA

• regulations and expectations wrt data requirement

Interested candidate can share their resume at Simran.Gill@glenmarkpharma.com