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Analyst - Regulatory Affairs print Print

Company Name: Dr Reddys Labs
Location: Hyderabad
Experience: 3 - 7 year(s)
Annual Salary: INR 900000 - 900000
Disability Accepted: Hearing Impairments (Hard of Hearing), Hearing Impairments (Total Deafness), Hearing and Speach Impairments, Intellectual Disabilities, Learning Disabilities, Locomotor Impairments, Mental Illness, Speech Impairments, Visual Impairments (Low Vision), Visual Impairments (Total Vision Loss), Developmental Disabilities
Vacancies: 2
Posted by : Fanny Mercy , 67 days ago

Job Description

Industry: Pharmaceuticals
Functional Area: Pharmaceuticals
Job Role : Analyst Regulatory Affairs, API
Job Description: • Knowledge of the regulatory guidance available with FDA, ICH, EMA, 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 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 a global development.
• 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 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.
• Maintain records to comply with regulatory requirements. Update and maintain paper/electronic document archival systems.

Desired Candidate Profile

Key Skills: Basic understanding of regulatory affairs, Knowledge in new product development, Basic knowledge in Analytical, Quality, cGMP, Manufacturing, IP.
Qualification: B.Pharm, M.Pharm, M.Sc
Candidate Profile: Technical Requirements:
• Basic understanding of regulatory affairs.
• Knowledge in new product development.
• Basic knowledge in Analytical, Quality, cGMP, Manufacturing, IP.

Key Personal Attributes:
• Self-starter, able to work & deliver with minimal supervision.
• Good communication and technical writing skills.
• Quick to learn & understand the regulatory procedures and guidance.
• Able to coordinate and collaborate with multiple functional teams across the organization.

Education & Experience:
M.Sc. / M.Pharm / B. Pharm with 3-7 years of experience.

Company Profile

Company: Dr Reddys Labs
Company Description: Refer company website

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