Dr Reddy’s Laboratories Ltd Hiring 2022 Dr Reddy’s Laboratories Ltd Notification full details below..Interested and eligible candidates can Apply Now.Dr. Reddy’s Laboratories is an Indian multinational pharmaceutical company located in Vishakhapatnam, Andhra Pradesh, India. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited. Dr. Reddy’s manufactures and markets a wide range of pharmaceuticals in India and overseas.
- Post Name: Regulatory Affairs Analyst – API
- Qualification: B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
- Experienced: Experience in NMPA/China Regulatory is preferred
Job Description: Dr Reddy’s Laboratories Ltd Hiring For Regulatory Affairs Analyst – API !
Important Details :
- Post of date:09/08/2022
- Location: Vishakhapatnam, Andhra Pradesh, India
- Selection Process: The selection will be on the basis of Interview.
Roles and Responsibilities
Knowledge of the regulatory guidance available with FDA, ICH, EMA, ANVISA (Brazil), NMPA (China), Russia, Japan and other regulatory agencies for APIs and fair understanding of the drug products approval cycle.
• Search & review the regulatory assessment reports (RLD / SBOA/EPAR/other literature evidences) available in regulatory websites or public domain and share the inputs with HPT for fixing the limits for impurities or defining the control strategy based on the maximum daily dosage.
• Must have sufficient chemistry knowledge to evaluate the synthetic schemes and aid in selection of appropriate regulatory starting materials for these complex APIs and define regulatory requirements for the selected starting materials in consultation with their managers.
• Participate in the technical discussions with the CFT for defining & finalizing the specifications for starting materials/intermediates/drug substance.
• Ensure GTI evaluation is carried out and necessary control strategies are put in place based on purge study, purge factors and/or routine or non-routine testing of the PGIs at appropriate stages. • Responsible for communicating the global & region specific regulatory requirements to CFT
• Review the documents received from CFTs and ensure quality of the technical reports and DMF.
• Responsible for responding to the regulatory deficiencies with adequate data and within stipulated timeline.
• Co-ordinate with GMO teams for Plant documentation needed for DMF preparation/deficiency responses/customer support.
• Stay well-informed of the regulatory procedures and the changing regulatory requirements. Must be aware of QbD principles, ICH guidelines to ensure their applications during product development and preparation of DMF submissions.
• Share the learning from regulatory deficiencies and updated regulatory guidelines with CFTs periodically during the daily meeting to integrate the requirements.
• Provide customer support by arranging technical packages, open part DMFs, and addressing customer queries in timely manner.
• Must have basic computer knowledge eg.MS-office, Chem Draw, etc. and hands-on in eCTD.
• Maintain records to comply with regulatory requirements. Update and maintain paper/electronic document archival systems.
How to Apply :
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