Dr Reddys Regulatory affairs Job vacancy in Hyderabad 2021

Dr Reddys Laboratories hiring Regulatory Affairs Analyst – API in Hyderabad Location

Education & Experience :

MSc / M Pharm with 5-8 years of experience in Regulatory Affairs

Advance Verbal and Written communication skills.

Basic understanding of API global regulatory affairs
proficiency in US and EU / China requirements

Experience in NMPA/China Regulatory is preferred

Basic knowledge in Analytical, Quality, cGMP, Manufacturing & IP



Key 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/othe 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.

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.

Fo more information & Application process check below Link

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