RA CMC Senior Manager

14 hours ago

Hyderabad Office, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Band

Level 4

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

Major 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 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.

Skills:

  • Change Control.
  • Cross-Functional Teams.
  • Documentation Management.
  • Negotiation Skills.
  • Project Management.
  • Regulatory Compliance.
  • Risk Assessment.
  • Risk Management.

Languages :

  • English.

Skills Desired

Change Controls, Cross-Functional Teamwork, Document Management, Negotiation, Project Management, Regulatory Compliance, Risk Assessments, Risk Management

  • RA CMC Senior Manager

    12 hours ago

    Hyderabad (Office), India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    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 Submission Coordinator

    2 days ago

    Hyderabad, Telangana, India Novartis Full time

    Summary Provide regulatory CMC operational submission and compliance support to department in accordance to defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle Major accountabilities Perform compliance and operational activities including QC check DA...

  • Regulatory Affairs Manager

    3 weeks ago

    Hyderabad, India Amgen Full time

    Job Description The 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 responsible for communicating the...

  • Ra Cmc Associate Manager I

    3 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    Summary -Responsible for regulatory activities specifically related to chemistry manufacturing and control CMC Activities such as the preparation and 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 Major accountabilities Author high...

  • RA CMC Associate Manager I

    5 days ago

    Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description Summary-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and 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 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    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 Key responsibilities Formulate and lead...

  • RA CMC Associate Manager I

    3 days ago

    Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    SummaryResponsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and 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.About the RoleMajor...

  • Regulatory Affairs Senior Manager

    2 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    The RA CMC Senior 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 Senior Manager is responsible for communicating the...

  • Regulatory Affairs Manager

    2 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 10,000 - ₹ 30,000 per year

    The 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 productsThe RA CMC Manager is responsible for communicating the regulatory strategy,...

  • CMC Delivery Lead

    3 weeks ago

    Hyderabad, India G&L Scientific Full time

    G&L Scientific have an immediate need for a CMC Delivery Lead to work with one of our clients.Please only apply if you can start immediately and can accommodate EU working hours. This position can based in our Mumbai or Hyderabad officeKey Skills and Experience Required:Demonstrated experience in CMC (Chemistry, Manufacturing, and Controls) for vaccines or...