RA CMC Senior Manager

5 days ago

Hyderabad, Telangana, India Sandoz Full time
Job Description

- Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines.
- Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.
- Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
- 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:

- Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation.
- No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control.
- Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines.
- Provides high quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems.
- Maintains collaborative partnerships with stakeholders.

Minimum Requirements:

Work Experience:

- Cross Cultural Experience.
- Operations Management and Execution.
- Collaborating across boundaries.
- Project Management.

  • RA CMC Manager

    23 hours ago

    Hyderabad, Telangana, India Sandoz Full time

    Job DescriptionMajor accountabilities:- Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.- Identify the required...

  • Ra cmc manager

    4 days ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description Summary -Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...

  • Ra Cmc Manager

    3 days ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description Summary -Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC).Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities.In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...

  • RA CMC Manager

    6 days ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description Summary -Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC) . Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...

  • RA CMC Manager

    6 days ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description Summary -Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC) . Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...

  • Ra Cmc Manager

    5 days ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description Summary-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC).Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities.In addition interact with HA's on REG CMC questions to support new product or post marketed launches. Job Description...

  • Ra Cmc Manager

    5 days ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description Summary -Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches. Job...

  • RA CMC Associate Manager-II

    2 weeks ago

    Hyderabad, Telangana, India myGwork Full time

    This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Summary -Responsible for regulatory activities specifically related to...

  • Ra Cmc Associate Manager-ii

    3 weeks ago

    Hyderabad, Telangana, India MyGwork Full time

    This job is with Novartis, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Summary -Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC).Activities such as the preparation...

  • Regulatory Affairs Manager

    5 days ago

    Hyderabad, Telangana, India Amgen Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Career CategoryInformation SystemsJob DescriptionThe RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is...