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 same
- Characterization 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
Role:Regulatory Affairs Compliance
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Functional Area:Legal & Regulatory
Role Category:Corporate Affairs
Employment Type:Full Time, Permanent
PG:MS/M.Sc(Science) in Any Specialization,M.Pharma in Any Specialization
Biophore India Pharmaceuticals Pvt. Ltd.
Biophore is a research driven global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs) having its operations based in Hyderabad, India and also has a registered office in New Jersey, USA. Biophore has two dedicated R&D facilities in Hyderabad and Vishakapatnam. The research facilities are fully equipped with wide range of R&D and process equipment from USA with reaction capabilities from milligram to kilogram. Ever since its establishment in 2007, Biophore recognized that there were two ways of growing the API business: manufacture a large API product basket, or pick a handful of promising APIs in select therapeutic categories and grow them over the long-term. Biophore consciously chose the latter option and focused on not only building competencies and adding scale in those segments but more importantly, building efficiencies that would make it an undisputed leader in these products of choice. The product range is constantly expanded through its own R&D, process development, technology transfers, joint ventures and collaborations. Biophores core strength lies in development of non – infringing routes for comprehensive range of bulk actives and intermediates, development of niche APIs, oncology APIs, APIs for MRI contrast agents and APIs for NCE - 1 filing. Biophore has made strategic investments in two manufacturing facilities. Sionc pharmaceuticals & Azico – Biophore, Both located at Vishakapatnam. Among them Sionc, a multi-purpose plant has passed FDA inspection in 2013 & 2016 with no observations on the Form 483. This is the reason to be proud and confirmation of the highest quality standards of Biophore. Our other facility Azico – Biophore is also a n FDA approved facility that strictly complies with cGMP procedures and maintains well documented SOPs, with a modern quality control laboratory thereby ensuring the production of highest quality APIs.