Ra Cmc Senior Manager

Year    Hyderabad, Telangana, India

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.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

Novartis

Beware of fraud agents! do not pay money to get a job

MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.


Related Jobs

Job Detail

  • Job Id
    JD3451941
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hyderabad, Telangana, India
  • Education
    Not mentioned
  • Experience
    Year