Dr. Reddy’s Hiring B Pharma & M Pharma Candidates – Apply Online
Dr Reddy’s Chemistry and Pharma job Dr Reddy’s. Chemistry jobs at Dr Reddy’s. Applications are invited for the Analyst temporary position. Interested and Eligible candidates with the chemistry filed may apply for this position at Dr Reddy’s. Check out all the details on Rasayanika.com your pharma & chemistry resource.
Job Title: Regulatory Affairs Analyst – API
Company: Dr. Reddy’s Laboratories
Location: Vishakhapatnam, Andhra Pradesh, India
Job: Regulatory Affairs Analyst
Level: Bachelor’s/Master/Equivalent Master
Skills List: Regulatory Affairs (China Regulatory is preferred)
Job Category: Full Time
Eligbility Criteria:
- B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
- 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
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.
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