3 Us Fda Jobs

Studying Legal Documents and collating info in a variety of formats. Ensuring compliance with regulations set by the Cosmetics & Perfumes Regulatory Agency as country wise Keeping up to date with changes in regulatory legislation and guidelines Required Candidate profile Well versed with US FDA, EU regulatory requirements Be well versed in the preparation of MSDS, COA, PIF and CPNP files Knowledge on Indian Drug & Cosmetic mfg Act especially on Schedule S Stds & GMP.

Role & responsibilities 1. Product Registration & Certification - Support in preparing the documentation as applicable for the product registration and the certifications and submitting in a timely manner. - Update the documents, for response to queries and other requirements as required by respective regulatory authorities in a stipulated time frame. 2. Regulatory Audits -Internal and External Audit - Provide assistance in Internal & External audits. - Draft, Internal audit reports and coordinate with auditors for the closure of audits in a timely manner - Assist with follow-up audits, as required. - Follow-ups for the closure against identified NCs during audits. 3. QMS-Maintenance - Compile and maintain regulatory documentation databases as per ISO 13485:2016 and other applicable regulatory requirements of - Identify the related and required documents in line with processes ensuring quality standards. - On-time release, distribution & obsolete documents as per the company procedure. - Maintain the QMS documentation, records and file maintenance. - Coordination with other departments for maintaining the documents. - Timely preparation and submission of MIS report on a daily/weekly/monthly basis. Preferred candidate profile Looking for Regulatory affairs professional Experience into Regulations and maintaining the documentation as per the ISO13485, USFDA, MDSAP and other regulations. Overall documentation and guidance to the departments to maintain regulatory compliance.

Role & responsibilities : CORPORATE QUAKLITY ASSURANCE 1. Specification Preparation & Documentation Develop and maintain specifications for raw materials (APIs, excipients) and packing materials. Ensure specifications comply with pharmacopeial standards and in-house quality standards. Review and update specifications based on regulatory updates, stability studies, and supplier changes. Coordinate with purchase, packaging development, QC, and regulatory teams for finalizing specifications. 2. Raw Material (RM) Specification Management Maintain records of Material Safety Data Sheets (MSDS) and Certificates of Analysis (COA) from suppliers. 3. Packing Material (PM) Specification Management Develop specifications for primary, secondary, and tertiary packaging materials. Ensure packing materials comply with stability, compatibility, and regulatory requirements. Conduct compatibility studies to assess interaction with drug formulations. Define parameters like GSM, burst strength, WVTR, dimensions, artwork compliance. 4. Regulatory & Compliance Assurance Ensure regulatory compliance with global standards (USFDA, WHO-GMP) Assist in audit preparation and responses related to material specifications. Ensure proper documentation and version control of Master Specification Files. 5. Vendor & Cross-functional Coordination Collaborate with vendors for RM & PM specification approvals. Work with Quality Control (QC), Quality Assurance, and Procurement to resolve material specification issues. Participate in vendor qualification, site audits, and material evaluation. 6. Acting as SPOC Between Factory & Corporate Serve as the primary liaison between the corporate QA team and the factory team regarding RM & PM specifications. Ensure smooth communication and implementation of corporate quality standards at the factory level. Address and resolve factory concerns related to RM & PM specifications in coordination with corporate QA. 7.Addressing Factory Concerns & Quality Compliance Resolve factory-level issues related to raw and packing materials by aligning corporate directives. Support factory teams in implementing quality control procedures for RM & PM. Ensure material handling, storage, and testing compliance at factory sites. Coordinate and support regulatory inspections and customer audits at manufacturing sites. Ensure timely CAPA (Corrective and Preventive Action) implementation post-audits. Maintain audit readiness across manufacturing and distribution facilities Design and approve the corporate documents to meet highest levels of quality standards. Conduct vendor audits and qualification for raw materials, packing materials, and contract manufacturers (P2P). Collaborate with the Procurement Department to ensure suppliers meet the required quality standards. Establish quality agreements with vendors and monitor compliance. specifications in coordination with corporate QA. Knowledge Required 1. 8 10years of relevant experience in Pharma industry. 2. Strong knowledge of pharmacopeia standards (IP, USP, BP, EP). 3. Expertise in specification writing and document management. 4. Knowledge of analytical techniques (HPLC, GC, UV, Titration, etc.). 5. Familiarity with ICH Q3C, Q6A, GMP, and GDP guidelines. 6. Knowledge of Specification Preparation of Raw Material / Packing Material / Finished Product 7. Knowledge of Pharmacopeia Monograph - Indian Pharmacopoeia / British Pharmacopoeia / United States Pharmacopoeia 8. Must have knowledge of General Testing Procedures related to Raw Material / Packing Material / Finished Product testing. 9. Must have proficiency in computer operating ( Specially MS Word ) 10. Able to communicate effectively with Factory Site and Purchase / RA Dept.. 11. Shall be able to communicate with Purchase Dept. related to P2P products. 12. Ensure cross-functional teams (Production, Purchase, Regulatory Affairs) are aligned with quality expectations. 13. Should be able to travel to third party site/s. 14. Should possess good verbal and written communication skills. 15. Exposure to regulatory agencies audits such as Schedule - M, USFDA, MHRA, WHO, ISO etc. Please note: Female candidate is preferred provided she should be able to travel outstation once in week on monthly basis.