Drug Regulatory Affairs

4 weeks ago

Kathua JK IN Sanctus Global Formulations Ltd. Full time

Ensuring Compliance Guaranteeing that drug development manufacturing and marketing align with national and international regulatory guidelines and industry standards Regulatory Submissions Preparing reviewing and submitting comprehensive dossiers and applications e g New Drug Applications NDAs Investigational New Drugs INDs to regulatory agencies like the FDA or EMA Documentation Management Overseeing the creation and maintenance of critical documents including clinical trial protocols product labels and promotional materials Liaising with Regulatory Agencies Serving as the primary point of contact and communication between the company and health authorities addressing concerns and facilitating approvals Interpreting Regulations Providing expert guidance on the interpretation and application of evolving regulations and guidelines to internal project teams and management Labeling and Advertising Review Ensuring that drug labels package inserts and marketing materials are accurate compliant and provide necessary information on use dosage and side effects Clinical Trial Support Collaborating with clinical research teams to ensure that clinical trials are conducted according to Good Clinical Practice GCP and meet regulatory requirements Post-Market Surveillance Assisting with ongoing compliance activities such as submitting periodic safety update reports PSURs and managing post-marketing surveillance data Skills and Qualifications Analytical Skills Ability to interpret complex regulations and scientific data Communication Skills Clear and effective communication to liaise with various departments senior management and regulatory agencies Attention to Detail Meticulousness in preparing precise and compliant documentation Knowledge of Guidelines Understanding of key regulatory guidelines such as Good Manufacturing Practice GMP Good Clinical Practice GCP and Common Technical Job Types Full-time Permanent Pay 25 000 00 - 35 000 00 per month Benefits Food provided Health insurance Paid time off Work Location In person

  • Drug And Excise Regulatory Affairs Executive

    2 weeks ago

    Panchkula, HR, IN Dr. Lormans Homeopathic Associates Pvt. Ltd. Full time

    Job Title Drug and Excise Regulatory Affairs Executive Company Dr Lorman s Homeopathic Associates Pvt Ltd Location Panchkula Haryana Reports To Regulatory Affairs Manager Senior Management Job Summary Dr Lorman s Homeopathic Associates Pvt Ltd is seeking a dedicated Drug and Excise Regulatory Affairs Executive to manage regulatory compliance and excise...

  • Regulatory Affairs Executive

    2 days ago

    Sirsa, HR, IN Inoovita Full time

    - We are looking for a Regulatory Affairs Executive for our client place based at Greater Noida Uttar Pradesh An ideal will be responsible for supporting new drug product registrations and maintaining current drug product registrations for International Market The role play a pivotal part in ensuring regulatory compliance timely submissions and successful...

  • Regulatory Affairs Executive

    2 weeks ago

    Kheda, GJ, IN Krishna Enterprise Full time

    Job Title Regulatory Affairs Executive - Cosmetics Personal Care Location Kheda - Gujrat EXP - 3 to 5 Years Job Summary - We are seeking a detail-oriented and proactive Regulatory Affairs Executive to ensure compliance of our cosmetics and personal care products with international regulatory requirements The ideal candidate should be experienced in...

  • Regulatory Affairs Executive

    3 weeks ago

    Panchkula, HR, IN Cosmetify Full time

    Job description 1 Prepare and submit regulatory documents with Food and Drug Administration for product approvals and renewals 2 Maintain up-to-date knowledge of regulatory requirements guidelines and industry trends 3 Maintaining BMR and BPR records 4 Checking and approving Products artwork 5 Support regulatory inspections and audits providing necessary...

  • Deputy Manager – Regulatory Affairs

    2 days ago

    Amarnath, MH, IN PolyPeptide Group Full time

    Job Title Deputy Manager - Regulatory Affairs Location Ambernath India Job Type Full Time Reporting Head of Regulatory Affairs Ambernath About Polypeptide Group PolyPeptide Group AG and its consolidated subsidiaries PolyPeptide is a specialized Contract Development Manufacturing Organization CDMO for peptide and oligonucleotide based active pharmaceutical...

  • Regulatory Affairs Executive

    1 week ago

    Verna, GA, IN Medizest Pharmaceutical Pvt. Ltd. Full time

    - Regulatory Affairs- Executive No of vacancy 01 Role Summary The Regulatory Affairs professional will be responsible for preparing reviewing submitting and maintaining regulatory documents to ensure compliance with national and international regulatory authorities The role ensures smooth product registration license renewals and compliance with all...

  • Drug Licensing Executive

    4 days ago

    Villupuram, TN, IN Simplita AI Full time

    Job Opening - Drug Inspector Co-ordinator Registered Pharmacist PAN India - Travelling Role Base Location Villupuram Work Coverage PAN India Industry Retail Pharmacy Healthcare Min 2-5 Years Experience in drug license registration Position Summary We are hiring a Drug Inspector Co-ordinator Registered Pharmacist for a PAN India travelling role to support new...

  • Pharma Regulatory Executive

    2 weeks ago

    Nimrana, RJ, IN Forty7 Interior Architect Full time

    Responsibilities Ensure product compliance with all relevant standards and regulations Developing and executing global regulatory strategies for drug development and product lifecycle management Leading regulatory submissions such as INDs Investigational New Drug applications NDAs New Drug Applications MAAs Marketing Authorization Applications and...

  • Regulatory Affairs

    3 weeks ago

    Ambala, HR, IN QVC CERTIFICATION SERVICES PRIVATE LIMITED Full time

    QVC CERTIFICATION SERVICES PVT LTD We are seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs Department as a Regulatory Affairs Specialist The ideal candidate will have a background in Biotechnology Microbiology Nanotechnology Omics Bioinformatics Genetics or related domains along with a strong understanding of...

  • Regulatory Affairs

    1 week ago

    Greater Noida, UP, IN Radicon laboratories ltd. Full time

    Job Title Regulatory Affairs RA Executive Officer Experience 1-5 years Pharma Industry Qualification B Pharm M Pharm M Sc Job Purpose To prepare review and submit all regulatory documentation required for product registration and ensure compliance with local and international regulatory agencies e g PICS EU ROW countries Key Responsibilities Prepare and...