5+

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.

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.

M.Sc/ Mpharm/ PhD; Deep understanding of various analytical tools and supporting software like Empower, OpenLab CDS, LabSolutions. And Chromeleon; This role focuses on analytical method development for route scouting, process development, and the scale-up of various crop protection products. The ideal candidate will have a skill set to operate and develop methods on GC-MS, LC-MS, and UPLC/UHPLC.

M.Pharm / MSc. in Analytical Chemistry / Organic Chemistry; Execute the Isolation projects. Carry out the isolation, purification of known and unknown impurities, compounds by preparative HPLC and characterization of molecules using various analytical techniques. Involve in project acceptance.

The job requires review of documents related to DMF submission against predefined checklists and submission to various agencies globally.  Should keep the all the regulatory database up to date. Candidate must possess do it right the first-time approach with proven track record. 

Exposure to OSD Manufacturing operations like Granulation, Compression, Coating, Pellet coating, Capsule filling, Primary Packing and Secondary Packing. Expertise in e-BPR and e-log will be added advantage.

PhD or Masters in Pharmaceutical Sciences, Biochemistry, Biotechnology, or related field with a focus on vaccine development or formulation science.