Dr. Reddys Laboratories Ltd. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products Dr. Reddys offer a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, and differentiated formulations.
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The major therapeutic focus is on gastrointestinal, cardiovascular, diabetology, oncology, pain management, and anti-infective. Major markets include India, USA, Russia-CIS, and Europe apart from other select geographies within Emerging Markets. For more information, log on to www.drreddys.com
Position: Regulatory Affairs Analyst – API
Location: Bachupally, Hyderabad, Telangana, India
- Knowledge of the regulatory guidance available with FDA, ICH, EMA, with expertise in ANVISA, other regulatory agencies for APIs, and fair understanding of the drug product approval cycle.
- Search & review the regulatory assessment reports (RLD / SBOA/EPAR/other literature evidence) 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 the 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 HPT 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 HPT for global development.
- Review the documents received from CFTs and ensure the quality of the technical reports and DMF.
- Responsible for responding to the regulatory deficiencies with adequate data and within a stipulated timeline.
- Co-ordinate with GMO teams 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 a timely manner.
- Must have basic computer knowledge eg.MS-office, Chem Draw, etc.
- Maintain records to comply with regulatory requirements. Update and maintain paper/electronic document archival systems.
Basic understanding of API global regulatory affairs & proficiency in Brazil/ANVISA requirements.
Experience: 2-5 Years
No of Openings: 2
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