Manager Regulatory Affairs Jobs in India

Ensuring compliance: Ensuring that a company's products comply with the regulations of the regions where they are distributedKeeping up with regulations: Keeping up to date with national and international legislation, guidelines, and customer practicesPreparing documentation: Preparing submissions for license variations and renewals, and other regulatory documentation

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

After 45 days of free training (technical) followed by 15 days (non technical), candidates can be placed in pharma company. During training candidate need to take care of living expenses including food accomodation and local travel.

Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy. Timely compile materials for license renewals, updates and registrations. Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners. Review labeling and labels for compliance with regulatory requirements Review changes to existing products and SOPs to define the requirements for regulatory submissions Provide the regulatory reviews of customer complaints and define the regulatory re-portability Responsible for timely registration of the facility Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products Actively participate in evaluation of regulatory compliance of document / product /process /test methods changes Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required

Roles and Responsibilities :Regulatory/ DMFAsking for necessary technical inputs from various departments in the Factories and doing its assessment.To give the necessary technical inputs required by the respective government departments (FDA, CDSCO ) under the guidance of the Head RegulatoryCompilation, review and submission of DMF (Drug master file) to Regulatory & ROW markets as per the given guidelines.To keep DMF files active as per the agency requirements.Revision/Renewal of CEP.Compilation & submission of Applicants part DMF (Drug master file) & QOS for customers.Compilation & Submission of RP DMF for authorities.Submissions of DMF Annual report to USFDASubmissions of DMF amendments to USFDAReply to the queries raised by respective authoritiesCustomer ServicingResponsible to address different questions and queries (technical) in the given time frame for customersTo get the necessary information from QA, QC for compilation and onward submission to regulatory authorities and customers as response to their queriesTo evaluate the technical agreements /CDA to be signed with the customers as on basis.Review of vendor questionnaire within the required timeframe along with supporting documents to customers and maintaining the record for the same.Preparation of the certificate of suitability for various customersPreparation/review of different kinds of declarations as per customer requirementsReview of change control, customer notification/intimationKeeping the track of customer notification/Intimation and response to the various queries raised by various customers & Log Maintenance Preparation of LOAs

Hi,we have an urgent vacancy in Regulatory Affairs for a pharmaceuticals company.experience - 2-12 yearsLocation - Ahemdabadinterested candidates, please share your resume or references on