Research and innovation are the mainstay of Biophores operations. The state-of-the-art technology development center located in Hyderabad is equipped with infrastructure that facilitates activities from conceptualization till regulatory approvals and further lifecycle management. This technology development center has dedicated laboratories for development of peptides, oncology products and other varied therapeutic segments. The research center integrates science with innovation to produce quality products meeting global regulatory standards.
We are hiring for Regulatory Affairs department .Details are mentioned Below .
- Education PG: MS/M.Sc(Science) in Organic Chemistry, Chemistry, M.Pharma in Any Specialization
- Experience : 3 Years to 07 years
- Department : Regulatory Affairs -API (US/Europe & Emerging Market )
- Openings: 10
- Salary; 4-8 Lacs P.A.
- Location: Hyderabad/Secunderabad
Walk-in interview Details
Interview Location :Biophore India Pharmaceuticals Pvt. Ltd.Plot# 231, IDA Phase -II, Pashamylaram,Biophore Road, Patancheru (M),Sanga Reddy District.Hyderabad.
Date & Time of Interview : 15th Sep 2023, Friday from 10:00 AM to 03:00 PM
Please go through the JD :
DMF submissions, Annual Reports, Variations, Renewals etc. for US and Europe market.
Compilation and publishing in eCTD/CTD format for Submission to health agencies like EDQM, USFDA etc.
Oversee final technical quality review and technical validation (PDF/eCTD/NeeS)
Review all regulatory agency submission materials for accuracy, comprehensiveness, or compliance with regulatory standards.
Provide deficiencies responses to HA regulatory agencies for deficiencies and comments
Evaluation of change controls for post-approval changes (PAC)
Compilation, review and submission of Variations
Keeping up to date with changes in regulatory legislation and guidelines
Conduct Pre-submission and Initial Submissions meetings
Preparation of gap analysis report of CMC regulatory submission including recommendations to facilitate the review of application by HA
Gaps in manufacturing and controls, assessment of regulatory risk and strategy
Providing gap analysis against applicable HA requirements and standards and communicate cross functional team to comply the samezCharacterization of the API and Raw materials used to manufacture the API
Description of the product and process development
Analytical methods and specifications used for testing
Release and stability testing data for both the API
Preparation of responses to HA,comment letters&assessment reports
Initial assessment of the submission (initial / post approval submissions) E.g., initial validation comments, response to the completeness assessment report, response to the Information Requests
