Regulatory Coordinator

2 hours ago

Hyderabad Telangana, India Novartis Full time

**Summary**:
Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.

**About the Role**:
Key Responsibilities
- Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA’s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers
- Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufacturing site transfers & new registration submissions word wide (as per health authority requirements).
- For new submissions - Represents Regulatory Affairs LCM BOE team in in NTO project team meetings, RA global and regional team meetings.
- Organize regulatory readiness with relevant line functions and with Country Organizations & Regions for timely delivery of submission and approvals
- Track progress of assigned projects, including timelines and dossier deliveries.
- Ensure quality and compliance with global regulatory requirements, countries requirements and adherence to regulatory internal policies and processes
- Support for maintaining country requirement lists and conducting need-based surveys & interaction with country organizations.
- Contribute to non-project related initiatives and excellence activities
- Support lessons learned sessions and trainings within and external to RA GDD leading to improve strategies and decisions on common regulatory approaches.

Minimum Requirements:

- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Minimum of 3-5 years of experience in Regulatory Affairs, related areas of the pharmaceutical Industry
- Good interpersonal and communication skills
- Ability to plan and prioritize work
- Ability to work effectively in a matrix environment
- Fluency in English - written and spoken

Why Novartis:
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Division

Development

Business Unit

Universal Hierarchy Node

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

  • Regulatory Coordinator

    2 days ago

    Hyderabad, Telangana, India Novartis Full time

    394724BR **Regulatory Coordinator**: India **About the role** Your responsibilities include, but are not limited to: - Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment, and New Investigator Submissions to ensure timely submissions in accordance with the FDA...

  • Regulatory Coordinator

    2 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    Summary Contributes and support the development of submission of product registration progress reports supplements amendments and or periodic experience reports Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment Key Responsibilities Ensure procurement of various...

  • Regulatory Coordinator

    2 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    **Summary**: - Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment. **About the Role**: **Major...

  • Regulatory Coordinator

    2 weeks ago

    Hyderabad, India Novartis Full time

    387033BR **Regulatory Coordinator**: India **About the role** Your responsibilities include, but are not limited to: - Support regulatory compliance activities, including entering product specific attributes as provided by program team representative into Regulatory Information Management System (RIM) (e.g. DRAGON). Provide support as needed for routine...

  • Regulatory Coordinator

    2 weeks ago

    Hyderabad, India Novartis Full time

    Your responsibilities include, but are not limited to:• Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment , and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations• Contribute to Module #1 documents including FDA...

  • Global Regulatory Manager

    4 days ago

    Hyderabad, Telangana, India Novartis Full time

    Summary Directs the development of submission of product registration progress reports supplements amendments and or periodic experience reports Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending...

  • Associate, Regulatory Writing

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    **India - Hyderabad** **JOB ID**: R-210832 **LOCATION**: - India - Hyderabad **WORK LOCATION TYPE**: On Site **DATE POSTED**: Apr. 03, 2025 **CATEGORY**: Regulatory **Roles and Responsibilities** - ** Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) to ensure...

  • Regulatory System Associate

    1 hour ago

    Hyderabad, Telangana, India Haleon Full time

    Job Purpose: The purpose of this role is to manage the regulatory information management (RIM) system for all Consumer Healthcare products worldwide to support key regulatory processes and enable the company to meet its regulatory, legal and pharmacovigilance obligations. This role is responsible for the operation of the regulatory systems and processes used...

  • Regulatory Specialist

    2 weeks ago

    Hyderabad, India MSN Laboratories Full time

    We are seeking a highly organized and detail-oriented Regulatory Project Coordinator/Manager to be the central point of contact between our Head Office (HO) and our Emerging Market country teams. This critical role ensures the seamless and timely delivery of all regulatory, technical, and administrative documentation required for product registration,...

  • Regulatory Specialist

    2 weeks ago

    Hyderabad, India Whatjobs IN C2 Full time

    We are seeking a highly organized and detail-oriented Regulatory Project Coordinator/Manager to be the central point of contact between our Head Office (HO) and our Emerging Market country teams. This critical role ensures the seamless and timely delivery of all regulatory, technical, and administrative documentation required for product registration,...