Assistant Manager

7 days ago

Noida, India Jubilant Generics Limited Full time

Job Summary:

  • Drug dossier authoring, reviewing & submission drug product application.
  • Management of product life cycle management (LCM) activities.
  • Assessment of post approval changes to secure successful product approvals & LCM.
  • Thorough knowledge of CMC requirements, labelling requirements, regulatory impact of post approval changes and regulatory life cycle management.


Key Responsibilities :

  • Drug dossier authoring, reviewing & submission of ANDAs (US).
  • Product life cycle management (LCM) activities.
  • Assessment of post approval changes.
  • eCTD publishing.
  • Thorough knowledge of CMC and Module 1 requirements.
  • DMF review and assessment, Query evaluation and response for under review ANDAs within timeline.
  • Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities.
  • Artworks (PIL, labels) and labeling files preparation, submission along with SPL preparation.
  • Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities.
  • Review and finalization of artwork / label as per current guideline.
  • Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends.
  • Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner.
  • Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements.
  • To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D / ADL against DMF / Dossier requirements.

Maintain regulatory files / database.

  • Assistant Manager

    2 weeks ago

    Noida, India S. Chand Publising Full time

    Role Description This is a full-time, on-site role for an Assistant Manager, located in Dadri. The Assistant Manager will oversee daily operations, manage team performance, and ensure the timely completion of projects. Duties include coordinating with different departments, ensuring compliance with company policies, and assisting in the development and...

  • Assistant Manager

    4 days ago

    Noida, Uttar Pradesh, India S. Chand Publising Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Role DescriptionThis is a full-time, on-site role for an Assistant Manager, located in Dadri. The Assistant Manager will oversee daily operations, manage team performance, and ensure the timely completion of projects. Duties include coordinating with different departments, ensuring compliance with company policies, and assisting in the development and...

  • Assistant Manager

    4 days ago

    Noida, Uttar Pradesh, India B2kart Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionWe suggest you enter details here.Role DescriptionThis is a full-time, on-site role for an Assistant Manager located in Noida. The Assistant Manager will oversee day-to-day operations, manage team performance, and ensure that goals and objectives are met. Responsibilities include monitoring staff, conducting performance evaluations, and...

  • Assistant Manager

    6 days ago

    Noida, Uttar Pradesh, India eBotics Solutions Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Company DescriptioneBotics Solutions is a service provider for Revenue Cycle Management services, bundled with Robotics Process Automation (RPA) services, catering to doctors, groups of doctors, clinics, hospitals, and other healthcare organizations. Our innovative solutions streamline operations, improve accuracy, and enhance productivity, ensuring our...

  • Assistant Manager

    2 days ago

    Noida, Uttar Pradesh, India KYG Estate X Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionKYG Estate X is a renowned name in the real estate industry, providing services for buying, selling, and renting properties. With extensive experience in residential, industrial, and commercial projects, the company offers comprehensive solutions for property transactions. As a leading investment advisory and brokerage real estate agency...

  • Assistant Manager

    2 weeks ago

    Noida, India CSL Finance Limited Full time

    Hi All, Kickstart your career with an exciting opportunity at CSLFinanceLtd , a certified Great Place to Work We're looking for a Assistant Manager – Accounts to be part of our growing team in Noida, Sector 16. Experience – 3 to 4yrs Preferred industry – Banks/ NBFC Education - B.Com/ M.Com Location - Noida Sector -16 Compensation is not a constraint...

  • Assistant Manager

    6 days ago

    Noida, Uttar Pradesh, India CSL Finance Limited Full time ₹ 6,00,000 - ₹ 10,00,000 per year

    Hi All,Kickstart your career with an exciting opportunity atCSLFinanceLtd, a certified Great Place to Work We're looking for a Assistant Manager – Accounts to be part of our growing team in Noida, Sector 16. Experience – 3 to 4yrsPreferred industry – Banks/ NBFCEducation - B.Com/ M.ComLocation - Noida Sector -16Compensation is not a constraint for...

  • Assistant Manager

    2 weeks ago

    Noida, India Infogain Full time

    Dear Candidates- We are looking to hire an Assistant Manager – Privacy to join our global security and compliance team. In this role, you will be responsible for supporting the execution of the organization’s data privacy strategy, aligning with evolving regulatory landscapes like GDPR, CCPA, DPDP Act (India), PDPA (Singapore),and others.- The ideal...

  • Assistant Manager

    2 weeks ago

    Noida, India The Indo Italian Chamber Of Commerce And Industry Full time

    Job Title: Assistant ManagerLocation: NoidaIndustry: Bureau of Indian Standard Testing Lab Textile & LeatherExperience: 2 - 5 yearsQualification: GraduateJob Overview We are seeking a detail-oriented and proactive Assistant Manager to manage operations related to handling and processing samples received from Italy for our textile and leather testing lab. The...

  • Assistant Manager

    2 days ago

    Noida, Uttar Pradesh, India The Indo Italian Chamber Of Commerce And Industry Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Job Title: Assistant ManagerLocation: NoidaIndustry: Bureau of Indian Standard Testing Lab Textile & LeatherExperience: 2 - 5 yearsQualification: GraduateJob OverviewWe are seeking a detail-oriented and proactive Assistant Manager to manage operations related to handling and processing samples received from Italy for our textile and leather testing lab. The...