The Regional Regulatory Lead is responsible for both strategic and operational regulatory activities within the assigned Therapeutic Area for designated products across regions including Asia Pacific (APAC), Latin America (LATAM), Commonwealth of Independent States (CIS), Adriatics, Middle East & Africa (MEA), and Partner Business. This role contributes to global regulatory strategy and manages regional regulatory strategies that align with commercial and business priorities, ensuring adherence to regional regulatory requirements and overseeing submissions related to marketing applications, life cycle management, tender applications, interactions with Health Authorities, PSURs, and associated reporting responsibilities.
Tasks
- Serve as the regional regulatory strategist for the assigned product portfolio and countries in alignment with the global strategy and priorities across designated regions or sub-regions.
- Develop and implement regulatory strategies that meet regional requirements for any regulatory activities, identifying the most efficient approval pathways by leveraging local inputs.
- Contribute to RST activities and support the development of Global Regulatory Strategy, including planning and preparation of projects or responses for complex scientific questions requiring product expertise and cross-functional collaboration.
- Lead the strategic oversight of regulatory activities across the assigned product portfolio and countries to drive optimal Health Authority outcomes and proactively anticipate and manage emerging regulatory risks.
- Provide strategic oversight to ensure high-quality regulatory submission documentation for all regulatory activities, including responses to Health Authority questions, aligned with schedules and regional requirements, while fostering a culture of continuous improvement.
- Build and maintain strong collaboration with Local Regulatory Representatives, Regulatory Partner Representatives, and other internal stakeholders.
- Build and maintain strong relationships with regional Health Authorities by delivering high quality, compliant regulatory documentation and engaging with clarity and influence to support positive outcomes for CSL.
- Stay current with international legislation and guidelines relevant to any CSL products and other key related CSL activities and initiatives.
- Act as a subject matter expert by assessing the impact of local or regional regulation and identifying potential regulatory risks.
- Contribute to continuous process improvements to enhance regulatory execution, compliance, and operational excellence.
Requirements
- A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification.
- Degree in Drug Regulatory Affairs advantageous.
- At least 5 years of regulatory experience within the international markets, supported by additional pharmaceutical or industry experience.
- English mandatory, and additional language is an asset (e.g. Arabic, French, Spanish, Russian).
- Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product and understanding of the principles of GMP, GCP.
Benefits
This is a unique opportunity to contribute to the delivery of life-changing therapies to patients worldwide while working within a collaborative and innovative global environment.
At CSL, we are committed to continuous improvement, scientific excellence, and making a meaningful difference in patients’ lives.
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