Regulatory Affairs Executive

Company Description

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