Briyosis Soft Caps Pvt. Ltd. is a privately-owned contract manufacturer of custom dietary supplement formulations. Based in Vadodara, India, we are an FDA registered and WHO-GMP certified company. With our high-efficiency encapsulation lines operating 24/7, we have the capability to produce over 3 billion soft-gels annually. Our 100,000 square feet facility encompasses production, laboratory, and warehousing space, and we adhere to FDA cGMP standards to ensure product quality and safety.
Role Description
Preparation of successful pharmaceutical license application to Global Regulatory agencies.
Reviewing regulatory documents such as manufacturing batch records, packaging batch records, analytical method, validation protocol and reports, stability protocol and record cards.
Responsible for compiling regulatory documents including Quality Module of Dossier for Global market as per regional requirements(s).
Preparation of dossier due-diligence report and identify timelines for all new projects that have been identified extended to other market for approved.
Providing training to new recruits and guide them through to understand the procedure well.
Keeping up to date mail communication with customer/partner and MOH regarding queries.
Maintenance of database with regulatory submission and approval.
Qualifications
B.pharm/M.pharm
Regulatory Affairs experience with a focus on dietary supplements
Knowledge of regulatory requirements and compliance standards
Experience in dossier preparation for regulatory submissions
Strong attention to detail and ability to manage regulatory documentation
Excellent communication and interpersonal skills
Ability to work independently and within a team
Proficiency in relevant software and tools used in regulatory affairs
Relevant certifications or qualifications in regulatory affairs or related field
Experience working in a manufacturing environment is a plus
Job Type: Full-time
Pay: ?25,000.00 - ?40,000.00 per month
Benefits:
Leave encashment
Provident Fund
Work Location: In person
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