Regulatory Affairs Chief

What You´ll Do:

• Leadership and strategy

  • Defines and implements the regulatory team’s strategic objectives, ensuring alignment with organizational goals and fostering collaboration.
  • Develops regulatory plans and strategies for new products and clinical line extensions, anticipating local and global requirements.
  • Serves as an internal consultant and facilitator to Quality and Operations teams, enabling efficient decision-making and execution
  • Reviews and ensures dossiers prepared by regulatory specialists are error-free and compliant with regulatory requirements.
  • Develops and implements Standard Operating Procedures (SOPs) to strengthen regulatory compliance and operational efficiency.
  • Ensures information systems related to regulatory submissions and approvals are consistently updated and maintained.
  • Oversees the review and approval of promotional materials, ensuring compliance with local and global standards and legal/quality requirements established by relevant authorities.
  • Reviews and approves final packaging artwork for assigned products, ensuring adherence to regulatory requirements and company standards.

• Integrated lifecycle responsibilities

  • Collaborates across multidisciplinary teams during Launch Readiness Reviews, ensuring objective alignment and effective execution of regulatory plans.
  • Coordinates and presents product quality information to the New Molecules Committee, enabling informed assessments and decisions.
  • Actively engages with the regulatory environment, staying current with evolving regulations, guidance, and health authority expectations.
  • Provides or coordinates local health authority contact and support during queries, inspections, or information requests.
  • Participates as a member of the drug project team to enable timely approvals and advantageous product information, aligned with business and market needs and compliant with relevant procedures.
  • Contributes to the planning, preparation (including authoring) and delivery of simple submissions, and supports more complex ones from a global and/or regional perspective across the product lifecycle.
  • Proactively liaises with cross-functional teams, providing regulatory advice on straightforward issues; coordinates the review of cross-functional inputs and consolidates regulatory comments to ensure submission quality.
  • Ensures appropriate, up-to-date records are maintained for compliance.
  • Champions a culture of courageous leadership, creativity, and collaboration.

Essential for the role:

• Professional degree related to the field (e.g. pharmacist, QFB, biotechnology)

• Knowledge of health care regulations, laws and  standards

• Analytical, written and oral communications skills

• Ability to work effectively in a team

• Advanced English.

• At least 5 years of experience within regulatory affairs or in a Health Authority

• Good written and verbal communication skills

• Performance Driven

Desirable:

• Experience in vaccines, biotechnological and orphans product.

• Experience with people management.

Date Posted

12-nov-2025

Closing Date

26-nov-2025

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.