USFDA Jobs

Key Responsibilities: Strategic Leadership: Develop and implement regulatory strategies for new and existing products, ensuring alignment with company objectives and global regulatory requirements. Submission Management: Prepare, review, and submit high-quality regulatory dossiers to regulatory agencies (e.g., FDA, EMA) for product registrations, variations, and renewals. Compliance Assurance: Monitor and interpret evolving regulations, guidelines, and standards to ensure ongoing compliance and proactively address potential risks. Collaboration & Communication: Collaborate effectively with cross-functional teams (R&D, Quality, Manufacturing) to provide regulatory guidance and support throughout the product lifecycle.Requirements: Regulatory Expertise: In-depth knowledge of global pharmaceutical regulations, guidelines, and standards (e.g., ICH, GMP). Strategic Thinking: Ability to develop and implement effective regulatory strategies aligned with business objectives. Communication & Collaboration: Excellent written and verbal communication skills with the ability to build strong relationships with internal and external stakeholders. Problem-Solving & Decision-Making: Analytical and problem-solving skills with the ability to make sound decisions in a complex regulatory environment. Leadership & Management: Proven ability to lead and motivate a team, providing guidance and support to achieve departmental goals.Education Required : Proven experience as a Regulatory Affairs Manager in the pharmaceutical industry. Strong understanding of drug development and manufacturing processes. Excellent knowledge of regulatory submission requirements and procedures

01Managing the entire QA activities in the plant & Overall implementation of Quality Systems in all units.02Design, Develop and approve all Quality systems in all units. Monitoring, Documentation, and implementation of process development.03Responsible to handle regulatory audits USFDA ISO 9001-14001, EU,WHO, and their compliance in all units without any Major Non Compliance.Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate; and Performing product quality reviews04Handling of statutory audits like Quality, EHS, KSPCB, -CDSCO, weight & scale inspector, Director of Factories & Boilers, Social audits etc and their compliance (Evaluated by No show cause notice and no complaints)05Making sure that critical deviations are investigated and resolved;06Approving all specifications and master production instructions, Test methods, Qualifications07Approving all procedures impacting the quality of intermediates or APIs08Making sure that quality related complaints are investigated and resolved09Adhering to QA budget.10To qualify company for various certifications.11Assuring QMS in all Units.

QC: ManagerHandle deviations, market complaints, change control, OOSInstrument calibration as per SOPPerform Method ValidationDevising, improving, and reviewing the procedures for products or processes.Preparation of SOPs if any required. Keep SOPs updatedClearing internal and external auditsDocument preparation (as per customers requirement)Ensure all the work of department has been managed effectively.Oversees the collection and production of samples to evaluate quality.Interpret blueprints for the purpose of establishing customers critical needs and how they should be measured.Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.Perform the quality inspection process of new part samples and record the data.Check dimensions and surface quality of random batches of finished products to ensure they meet all company quality standards.Inspect all product returns, analyze the defect, and document the findings.Verify all processes are conforming to established quality standards and required customer specifications.Carries out ongoing lab and field sampling. Auditing visual, dimensional, and mechanical tests of materials and processes.Interpret test results, compare them to established specifications and control limits, and make recommendations on the appropriateness of data for release.Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.Investigate customer complaints regarding quality issues and develop a solution.Record, compile and prepare reports for analysis and evaluation.Assist in the development of needed records and standards and maintain accurate and detailed files as required.Instruct the method of disposition of discrepant material.Assist in designing and implementing the procedure for the use of Statistical Process Control across all departments as required.

To review the documentation of manufacturing and packaging.Retrieve electronic scans and review batch records based on cGDP, cGMP, CPCs SOPs, and FDA guidelines.To perform batch data entry for APR and process validation.Preparation of Annual Product Review / Product Quality Review reports.To review the process validation report.