Regulatory Affairs Chief

What You´ll Do:

• Leadership and strategy

  • Defines and implements the regulatory team’sstrategic objectives, ensuringalignment with organizational goalsand fostering collaboration.
  • Developsregulatory plans and strategiesfornew productsandclinical line extensions, anticipating local and global requirements.
  • Serves as aninternal consultant and facilitatortoQualityandOperationsteams, enabling efficient decision-making and execution
  • Reviews and ensuresdossiersprepared by regulatory specialists areerror-freeand compliant with regulatory requirements.
  • Develops and implementsStandard Operating Procedures (SOPs)to strengthenregulatory complianceandoperational efficiency.
  • Ensuresinformation systemsrelated toregulatory submissions and approvalsare consistentlyupdated and maintained.
  • Oversees thereview and approvalofpromotional materials, ensuring compliance with local and global standards and legal/quality requirements established by relevant authorities.
  • Reviews and approvesfinal packaging artworkfor assigned products, ensuring adherence to regulatory requirements and company standards.

• Integrated lifecycle responsibilities

  • Collaborates across multidisciplinary teams duringLaunch Readiness Reviews, ensuringobjective alignmentand effective execution of regulatory plans.
  • Coordinates and presentsproduct quality informationto theNew Molecules Committee, enabling informed assessments and decisions.
  • Actively engages with theregulatory environment, staying current with evolving regulations, guidance, and health authority expectations.
  • Provides or coordinateslocal health authority contact and supportduring queries, inspections, or information requests.
  • Participates as a member of thedrug project teamto enabletimely approvalsandadvantageous product information, aligned with business and market needs and compliant with relevant procedures.
  • Contributes to theplanning, preparation (including authoring)and delivery ofsimple submissions, and supports more complex ones from aglobal and/or regionalperspective across the product lifecycle.
  • Proactively liaises withcross-functional teams, providingregulatory adviceon straightforward issues; coordinates thereview of cross-functional inputsand consolidates regulatory comments to ensuresubmission quality.
  • Ensuresappropriate, up-to-date recordsare maintained forcompliance.
  • Champions a culture ofcourageous leadership,creativity, andcollaboration.

Essential for the role:

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

• Knowledge of health care regulations, laws and standards

• Analytical,writtenandoralcommunicationsskills

• 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.

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 authorisation and employment eligibility verification requirements.