AstraZeneca Regulatory Affairs Job

AstraZeneca Regulatory Affairs Job – Apply Online

iCMC Regulatory Affairs Manager I

Posted date: Jan. 16, 2025

Contract type: Full time

Job ID: R-214621

Introduction to role

As an iCMC RA Manager I, you will effectively handle the production of Chemistry, Manufacturing, and Control (CMC) documentation for designated product ranges to meet the needs of both AstraZeneca and our customers. You will project manage international CMC regulatory submissions, ensuring that project activities and documentation are delivered to the required standards across the product lifecycle. You will chip in to and lead the regulatory CMC components of business-related projects, maintaining effective communication with collaborators and project team members to ensure relevant timelines and regulatory commitments are met. Additionally, you will ensure the application of international CMC regulations and guidance within AstraZeneca and chip in to the development of new guidance, policy, and processes.

Accountabilities

  • Manage the timely preparation (including authoring) and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout the lifecycle, including marketing authorization applications and all post-approval activities.
  • Accountable for delivering “submission ready” CMC modules to internal and external regulatory team members in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality.
  • Document maintenance and communication of Health Authority approval status.
  • Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions.
  • Demonstrate project management expertise with the ability to adapt to changing situations to ensure on-time delivery.
  • Share learnings from own projects with colleagues/within functions.
  • Support the agreed strategy to employ fit-for-purpose content applying regulatory intelligence and optimize proposed submission content.
  • Participate in regulatory execution and delivery meetings, providing relevant updates to the CMC team.
  • Contribute to business process optimization activities to reduce waste and ensure efficiency.
  • Continually evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses, and commitments.
  • Apply GxP principles according to the stage of the product lifecycle.
  • Responsible for organisational change as assigned.
  • Understand the application of appropriate risk management across own activities.
  • Demonstrate research skills in understanding regulations and guidance from different regulatory agencies.

Essential Skills/Experience

  • University degree in a science or technical field such as pharmacy, biology, chemistry, or biological science.
  • Minimum 8 years of proven experience from the biopharmaceutical industry or other relevant experience.
  • Breadth of knowledge of manufacturing, project, technical, and regulatory management.
  • IT skills.
  • Collaborator & project management.
  • Professional capabilities: Regulatory knowledge.

Desirable Skills/Experience

  • Knowledge of the drug development process and regulatory submissions.
  • Understanding of current regulatory CMC requirements.
  • Direct/indirect Regulatory Affairs CMC experience with submissions for synthetics and/or biologic and biotechnology-derived products such as monoclonal antibodies or complex biologic products.
  • Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies.
  • Lean capabilities.

APPLY ONLINE HERE

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