Regulatory Coordinator

7 days 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 accountabilities**:

- Achieve the best product registration with commercially attractive labelling in accordance with registration plan -Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance -Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.) -Foster and maintain good relations with internal and external stakeholders -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

**Key performance indicators**:

- Project & stakeholder feedback -Product license update in terms of CMC in agreed timeline -Adherence to Novartis policy and guidelines

**Minimum Requirements**:
**Work Experience**:

- Functional Breadth.
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.

**Skills**:

- Analytical Skill.
- Clinical Trials.
- Collaboration.
- Detail Oriented.
- Lifesciences.
- Project Planning.
- Regulatory Compliance.

**Languages**:

- English.

Division

Development

Business Unit

Innovative Medicines

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

    7 days 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...

  • Global Regulatory Manager

    4 weeks 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

    1 week 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...

  • Associate Regulatory Writing

    1 day ago

    Hyderabad, Telangana, India Amgen Full time

    **ABOUT AMGEN** Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the...

  • Analyst Regulatory Affairs

    6 days ago

    Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time

    Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20 employees...

  • Regulatory Data

    1 week ago

    Hyderabad, Telangana, India Amgen Full time

    **India - Hyderabad** **JOB ID**: R-206528 **LOCATION**: - India - Hyderabad **WORK LOCATION TYPE**: On Site **DATE POSTED**: Feb. 17, 2025 **CATEGORY**: Regulatory Roles & Responsibilities: - Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory...

  • Regulatory Data

    1 week ago

    Hyderabad, Telangana, India Amgen Full time

    **India - Hyderabad** **JOB ID**: R-208732 **LOCATION**: - India - Hyderabad **WORK LOCATION TYPE**: On Site **DATE POSTED**: Mar. 14, 2025 **CATEGORY**: Regulatory Roles & Responsibilities: - Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory...

  • Associate Regulatory Affairs

    7 days ago

    Madhapur, Hyderabad, Telangana, India Makrocare Full time

    Company Description **MakroCare |** **_A MakroGroup Company_**- MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

    Hyderabad, Telangana, India Medtronic Full time

    At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all You ll lead with purpose breaking down barriers to innovation in a more connected compassionate world A Day in the Life Supporting Design and Development Control activities with regulatory requirements direction tactics and...

  • Regulatory Affairs

    4 days ago

    Hyderabad, Telangana, India Talental Consultings Full time

    Designation Senior Executive Assistant Manager Manager Sr Manager based on experience Industry Pharmaceutical - API Manufacturing Experience 3-15 Years flexible Qualification M Sc Chemistry or equivalent Key Responsibilities Prepare compile review and submit regulatory dossiers for APIs for Regulated markets Handle DMF Type II ASMF CEP and CTD eCTD...