Drug Regulatory Affairs

4 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

  • Science Academic Executive

    4 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...

  • ▷ (Apply Now) Senior Pharmacist

    7 days ago

    Tiruchchirappalli, TN, IN SUNDARAM HOSPITAL Full time

    Job Title Senior Pharmacist Job Summary The Senior Pharmacist is responsible for overseeing pharmacy operations ensuring safe and effective dispensing of medications mentoring pharmacy staff and maintaining compliance with regulatory and clinical standards The role includes providing expert pharmaceutical guidance monitoring drug use and...

  • ▷ [Only 24h Left] Qa-art Approval

    7 days ago

    Karnal, HR, IN Sarthak Biotech Private Limited Full time

    We are seeking an experienced QA- Art Approval Person for our pharmaceutical company The ideal candidate will have a proven track record in a similar role within a highly regulated industry Key Responsibilities Review and approve all packaging artwork including labels and cartons for compliance with regulatory standards Proofread artwork...

  • Pharmacist

    4 days ago

    Payyannur, KL, IN SANS POLY CLINIC Full time

    Job Summary We are seeking a dedicated and detail-oriented Pharmacist to join our small clinic team The ideal candidate will be responsible for dispensing medications providing drug-related advice to patients and medical staff and ensuring compliance with all regulatory requirements This role involves both clinical and administrative duties in a...

  • Quality Analyst

    4 days ago

    Gajraula, UP, IN TAPI Full time

    Company Description At TAPI we re not just a company we re a community committed to advancing health from the core As the world s leading supplier of active pharmaceutical ingredients APIs we partner with 80 of the top 50 global pharmaceutical companies With a legacy spanning over 80 years and a portfolio of more than 350 products as well as...

  • R&d Executive

    14 hours ago

    Una, HP, IN Hindustan FarmDirect Ingredients Private Limited Full time

    Key Responsibilities Prepare review and maintain technical documents such as product development reports SOPs specifications protocols and technical data sheets Ensure all documentation complies with regulatory quality and company standards such as ISO GMP FDA etc where applicable Maintain version control track revisions and ensure...

  • ▷ (26/09/2025) Company Secretary

    15 hours ago

    Anand, GJ, IN Infinium Pharmachem Pvt Ltd Full time

    INFINIUM PHARMACHEM LIMITED is an NSE Listed well known Pharmaceutical Intermediates APIs manufacturing company since 2003 We are looking for enthusiastic and well experienced candidate for post of Company Secretary for the Company Post Company Secretary Qualification Min 2 to 4 Years of experience as a qualified CS Job profile All...

  • Senior Executive-supply Chain

    15 hours ago

    Mahad, MH, IN Piramal Enterprises Full time

    Responsible Accountable for smooth timely dispensing of Raw Materials for Liquid N-Block and Vitamin Mineral Premix products Partially responsible Accountable for compliance with Rules regulations of Goods Service Act Partially responsible Accountable for compliance with Legal Metrology Weights Measures Act Ensuring avoidance of breach of...

  • Qc Officer

    4 days ago

    Sanand, GJ, IN Kashmik Formulation Private Limited Full time

    We are seeking a detail-oriented and experienced Quality Control Officer to handle stability testing and documentation as per regulatory guidelines ICH WHO USFDA etc The role involves routine and accelerated stability studies sample analysis and maintaining GMP-compliant records Key Responsibilities Conduct physical and chemical stability...

  • Manager – Formulation Development

    4 days ago

    Kheda, GJ, IN Gujarat Construction Full time

    Job Title Manager - Formulation Development ROW Markets Department Research Development R D - Formulation Development Location Kheda Ahmedabad Reporting To Head - Formulation Development R D Director Role Objective To lead and manage formulation development activities for pharmaceutical products targeted at ROW Rest...