Manager Regulatory Affairs Jobs in India

Qualification / ExperienceBachelor's/Masters degree in Law (LLB/LLM) .3-7 years of experience in land acquisition matters, preferably in the renewable energy sector.In-depth knowledge of land acquisition laws, property registration, and regulatory approvals.Experience in dealing with government agencies, revenue departments, and local authorities.Fluency in Hindi, Marathi, English.Key Responsibilities:Conduct legal due diligence and verify all land records .Engage and liaison with landowners, government officials Lawyers & cross functional teams for land acquisition, approval and clearness, project finance and regulatory compliance.Manage and mitigate ROW disputes, and other legal disputes.Maintain a comprehensive database of land records & legal documentation and appraise the management on daily activity.

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

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

Export Executive (Pharma) Job Responsibilities:Lead Generation: Identify and generate new buyer leads in international markets.Client Convincing: Engage with potential clients, present products, and convince them for sales.Documentation: Manage all export documentation, including regulatory, shipping, and compliance papers.Client Communication: Maintain regular communication with clients to ensure smooth transactions.Order Processing: Oversee the processing of international orders and ensure timely delivery.Compliance: Ensure adherence to global export regulations and pharma standards.Follow-up: Follow up on payments, orders, and customer feedback to build long-term relationships.Key Skills:Strong communicationClient relationship managementDocumentation & regulatory knowledgeMarket researchAttention to detailNegotiation skills

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.

1. Issuance and retrieval of Authorized documents (viz. Formats, Logbooks) to concerned department personnel.2. Prepare and review of IPQA related documents. 3. Ensure every employee follows GDP.4. Line clearance and verification for various production activities and dispatch as per procedures.5. Ensure to follow the sampling plan in the respective areas.6. Verification of logbooks in the respective areas.7. Segregations and filling of executed batch documents received from concerned department.8. Review of Batch records and Preparation of batch review checklists and batch release certificate.9. To perform daily walkthroughs in the respective areas.10. Basic knowledge on the Electrical/Electronic components.11. Ensure the Quality Standards are followed across the manufacturing site.12. Good Communication Skills.13. Excellent data collection and analysis skills.14. Good Knowledge in relevant regulatory standards.

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

i. Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.ii. Identifies and sets appropriate quality standards and parameters for products.iii. Communicates quality standards and parameters to QA team, product development team, and other appropriate staff.iv. Coordinates product testing processes.v. Participates in product testing.vi. Identifies and analyses issues, bugs, defects, and other problems, particularly when problems recur in multiple products; recommends and facilitates solutions to these issues.vii. Reviews client, customer, and user feedback.viii. Maintains compliance with central, state, local, and organizational laws, regulations, guidelines, and policies.ix. Performs other duties as assigned.x. Hires and trains quality assurance staff.xi. Oversees the daily workflow and schedules of the department.xii. Conducts performance evaluations that are timely and constructive.xiii. Handles discipline and termination of employees in accordance with company policy.

Designation: Sr. Officer / Executive/ Sr. Executive (Regulatory Affairs USA, EU, JAPAN,ANVISA, TGA market)Experience:- 3 to 6 years' work experience in international and domestic Pharma regulatory affairs.- Confirmed knowledge of Global market regulatory requirements and ICH guidelines.- Should have experience in eCTD DMF/Dossier preparation and review including life cyclemanagement, specifically CMC writing & preparing module 1, 2 and 3 previously.- Should have experience in handling of changes notification to customers and agencies- Should have experience in renewal of facility registrations and drug listing activities.- He/she has to work independently. There is no scope for supervision or team handling.- Only M.Sc Chemistry preferably or complete experience in API industry for BPharm /MPharm .Job Responsibilities:- Preparing DMF/dossiers for regulated and semi-regulated markets.- Preparation of documents for domestic license permissions.- Gathering, evaluating, organizing and managing drug substances and intermediatesregulatory information in a variety of formats.- Handling of change notifications with the customers and regulatory agencies- Maintaining Regulatory database up to date.- Address customer complaints and queries within agreed timelines.- Attending various customer and health authority audits held at the manufacturing site- Keeping up-to-date with changes in regulatory legislation and guidelines- Writing comprehensible, user-friendly, clear process description and impurity profile- Ensuring that high quality standards are met and submissions meet strict deadlines.Primary Skills:Understanding on API process and analytical methods development flowKnowledge on impurity profile, analytical method validations and stability studies.Knowledge on eCTD submission structure.Fluency in oral and written English.Able to build and maintain good communication with cross functional departments

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