Biophore India Pharmaceuticals Pvt. Ltd Walk In Interview 2023. Biophore India Pharmaceuticals Pvt. Ltd Notification full details below. Interested and eligible candidates can attend interview on scheduled time and venue. Founded in 2007, Biophore has established itself as a trusted partner for niche and complex products. With 4 US FDA and EU approved API manufacturing facilities, one dedicated intermediate facility and a world class R&D lab housing 400 scientists with varied expertise, Biophore has emerged as one of the leading API companies globally.
Vacancy details:
- Department: Executive/Sr.Executive- Regulatory Affairs (API)
- Qualification: M.Pharma in Any Specialization, MS/M.Sc(Science) in Organic Chemistry
- Experienced:3-6 Years.
- Openings: 05
Job Description: Greeting from Biophore India Pharmaceuticals Pvt. Ltd !!!!
Important Details :
- Location: Pashamylaram, Patancheruvu
- Post of date:25/07/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face interview
- Interview Rounds of Interview: HR
This is an opportunity with Biophore in Regulatory affairs -API Department .
Please go thorough the JD. Interested candidates share your CV’s to “recruitments@biophore.com“.
Location : Pashamylaram, Patancheruvu .
Job description :
Roles and Responsibilities
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
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