November 2024

Filling machine Groninger, Optima, Dyno Truking filling and sealing machine, Bosch filling machine, Steam sterilizer Fedegree

The Regulatory Affairs Manager II is fully proficient in applying established standards and performs regulatory affairs management for moderately to highly complex international market submissions in all regions with minimal coaching. They are expected to facilitate strategic input, provide proactive contribution to submission planning, identify areas for continuous improvement, and lead cross-functional activities. They participate in the continuous improvement of processes and tools, systems.

Ph.D. in Science, Engineering, Technology, Veterinary Science, Pharmacy. Candidate must possess certificate, marksheet of basic knowledge of Computer from training institute or should have results with computer as a subject in degree or diploma curriculum from Government approved University or should have passed 10th or 12th examination with computer as a subject as prescribed by GAD in Government Resolution

MSc. with 1st Class in Genetics,Human Genetics, Life Sciences, Biochemistry from recognized university and suitability bases on CSIR, UGC, ICMR, DBT, etc.

M.Sc./M.Tech. (Applied Biology / Biochemistry / Bioinformatics / Biophysics / Biotechnology / Botany / Life Sciences / Microbiology/ Molecular Biology / Zoology or related Biological Sciences, Physics / Chemistry / Mathematics) / M.V.Sc./ M.Pharm.

M.Sc Chemistry from a recognized University, Institute. Sound knowledge of marker analysis by HPTLC and HPLC. Method development and validation by HPTLC and HPLC Skills of drafting, editing of scientific documents/ articles, technical reports etc.

Method validation, verification and transfer to Quality control lab for OSD and PFOS formulations. Development, optimization and validation of analytical methods to support OSD formulation ANDA.

Aurobindo Pharma Limited is an Indian multinational pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad, India.

Knowledge of regulatory guidelines applicable to formulation development. Must have handled ER, MR, Pellets drug products for US and EU market.