Regulatory Affairs Manager

4 days ago


Midrand, Gauteng, South Africa Novartis Full time
About the Role

Key Responsibilities:

  • Support the development and implementation of regulatory strategies for product registration, maintenance of registered base portfolio, and clinical trials.
  • Monitor and communicate regulatory requirements, intelligence, and policy to facilitate strategic planning for product registration, maintenance of registered base portfolio, clinical trials, policy shaping, capability building, and harmonization initiatives across assigned geographies.
  • Collaborate with internal stakeholders and establish strong working relationships with key external stakeholders to drive regulatory compliance and process improvements.
  • Support key projects and initiatives, such as streamlining operations, accelerating key submission projects, and policy initiatives.
  • Develop and maintain dashboards and trackers to improve regulatory processes within the cluster.
  • Contribute to the development of policy strategies and advocacy plans.
  • Ensure compliance with current local regulations, including awareness of current and new local regulations and timely communication of changes to relevant stakeholders.
  • Align local working procedures with Global processes and identify areas for process improvements.
  • Oversee the accurate and timely maintenance of RA Regulatory databases.
  • Manage deviations and related CAPAs, ensuring timely feedback to compliance-related queries and surveys from various stakeholders.
  • Ensure issues of non-compliance are handled with urgency and compliance to global and local KPIs.

Key Performance Indicators:

  • Recognized as a competent and reliable partner in driving regulatory policy, strategic operations, and compliance.
  • Successful support of implementation of regulatory strategies resulting in product registration and clinical trials approvals.
  • Proactive communication of new and evolving regulatory requirements to relevant stakeholders.
  • Successful elaboration and execution of the cluster regulatory Policy strategy.
  • Successful creation of required dashboards and trackers to help streamline operational and reporting of activities.
  • Achievement of Regulatory compliance deliverables as per global/regional/cluster targets.
  • Timely and accurate tracking and reporting.
  • Proof of implementation of process improvements associated with compliance.
  • Addressing issues related to compliance with urgency.
  • Integrity & Compliance: Works with Integrity & Compliance policies and all company policies.


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