Drug Regulatory Affairs

2 days 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 Regulatory Affairs

    1 week ago

    Kathua, India ASSOCIATED HEALTHCARE PRIVATE LIMITED Full time

    Ensuring Compliance:Guaranteeing that drug development, manufacturing, and marketing align with national and international regulatory guidelines and industry standards. - Documentation Management:Overseeing the creation and maintenance of critical documents, including clinical trial protocols, product labels, and promotional materials. - Liaising with...

  • Regulatory Affairs Executive

    3 weeks ago

    Kheda, GJ, IN Krishna Enterprise Full time

    Job Title Regulatory Affairs Executive - Cosmetics Personal Care Location Kheda - Gujrat Compensation up to 6 LPA EXP - 4 TO 7 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...

  • Regulatory Affairs Executive

    4 weeks ago

    Kheda, GJ, IN Krishna Enterprise Full time

    Job Title Regulatory Affairs Executive - Cosmetics Personal Care Location Kheda - Gujrat - 3 to 5 Years of exp Compensation up to 6 LPA 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...

  • Executive - Regulatory Affairs

    1 week ago

    Bhiwadi, RJ, IN B. Braun Full time

    You re an important part of our future Hopefully we re also a part of your future At B Braun we protect and improve the health of people worldwide You support this vision bringing expertise and sharing innovation efficiency and sustainability as values That s why we would like to keep developing our company with you Keeping your future in mind we re making a...

  • Manager: Qa

    2 hours ago

    Panchkula, HR, IN Mother Sparsh Baby Care private Limited Full time

    Job Title Senior Manager - Quality Assurance Regulatory Affairs Department Quality Compliance Industry Skincare Cosmetics Location Panchkula Reports To Head- Purchase Operations Job Summary We are seeking an experienced and detail-oriented Senior Manager - Quality Assurance Regulatory Affairs to lead and oversee all quality and regulatory functions within...

  • Drug Safety Associate

    2 weeks ago

    Amravati, MH, IN Fusion Technology Solutions Full time

    key duties Monitoring and Reporting Tracking and documenting adverse drug reactions ADRs and ensuring they are reported to regulatory authorities Data Collection Analysis Reviewing clinical trial and post-marketing data to identify trends in drug safety Compliance Ensuring adherence to regulatory guidelines and company policies regarding drug safety and...

  • Regulatory Specialist

    2 weeks ago

    Thane, MH, IN Mondel?z International Full time

    Are You Ready to Make It Happen at Mondel z International Join our Mission to Lead the Future of Snacking Make It With Pride You execute the regulatory affairs strategy for your respective category or categories and geographical area using your technical and regulatory knowledge You ensure our policies regulatory programs and requirements of our portfolio...

  • Science Academic Executive

    3 days ago

    Cuttack, OR, IN ALEGRIA LABS PVT,LTD Full time

    Position Summary The Science Academic Executive supports the development and implementation of scientific strategies This role facilitates scientific collaborations enhances the company s academic presence and ensures alignment between corporate goals and academic scientific trends Key Responsibilities Academic Engagement Liaison Develop and manage...

  • Subject Matter Expert

    5 days ago

    Panchkula, HR, IN Edu Tap Learning Solutions Full time

    Turn your academic excellence into aspirants success stories Join us as Subject Matter Expert and turn your subject brilliance into bite sized subject materials our students can rely on About EduTap At EduTap we are on a mission to make every student who comes in touch with us feel safe guided and mentored We provide online coaching of regulatory body exams...

  • [Urgent Search] Pharmacist

    3 weeks ago

    Tamluk, WB, IN Thr Neotia University Full time

    Job Title PharmacistLocation Tamluk West BengalRegistration Must be registered under the West Bengal State Pharmacy Council WBSPC Job Summary The pharmacist will be responsible for dispensing medicines as per the doctor s prescription maintaining inventory ensuring proper storage of drugs and complying with the Drugs and Cosmetics Act and Pharmacy Act 1948...