Regional Regulatory Lead

CSL; Glattbrugg; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

CSL is seeking a Regional Regulatory Lead to drive regional regulatory strategies across APAC, LATAM, CIS, Adriatics, MEA and Partner Business. Based in Zurich or Maidenhead, the role partners with the Global Regulatory Lead to align regulatory plans with commercial priorities.

You will manage submissions, lifecycle activities, Health Authority interactions, and risk planning while supervising cross-functional collaboration with LRRs and RPRs to ensure timely approvals and high-quality

Qualifikationen

• A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification.
• At least 5 years of regulatory experience within international markets.
• English mandatory; additional language skills are a plus (e.g., French, Spanish, Russian).
• Understanding of GMP and GCP principles and pharmaceutical development requirements.

Aufgaben

• Serve as regional regulatory strategist for designated regions in alignment with global strategy.
• Develop and implement regional regulatory strategies meeting regional requirements and approval pathways.
• Contribute to global regulatory strategy and plan complex scientific questions with cross-functional teams.
• Lead strategic oversight of regulatory activities to drive optimal Health Authority outcomes.
• Ensure high-quality regulatory submission documentation and timely responses to authorities.

Kenntnisse

Regulatory strategy development

International regulatory experience

GMP/GCP knowledge

Stakeholder collaboration

English proficiency

Ausbildung

Biological/Medical Science or Pharmacy degree

Jobbeschreibung

The Regional Regulatory Lead (RRL) is responsible for both strategic and operational regulatory activities within the assigned Therapeutic Area (TA) for designated products across designated regions or sub-regions: Asia Pacific (APAC), Latin America (LATAM), Commonwealth of Independent States (CIS), Adriatics, Middle East & Africa (MEA) and Partner Business. The RPL can be based at either of the following sites: Zurich (Switzerland), or Maidenhead (UK).

Working with the Therapeutic Area Lead and the Global Regulatory Lead, the RRL contributes to global regulatory strategy and manages regional regulatory strategies that align with commercial and business priorities.

This position ensures adherence to regional regulatory requirements and oversees submissions related to marketing applications, life cycle management, tender applications, interactions with Health Authorities, PSURs, and associated reporting responsibilities. The RRL partners with Local Regulatory Representative (LRR), Regulatory Partner Representative (RPR), and other internal stakeholders to facilitate timely Health Authority approvals.

Key Responsibilities

• 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: Asia Pacific (APAC), Latin America (LATAM), Commonwealth of Independent States (CIS), Adriatics, Middle East & Africa (MEA) and Partner Business.
• Develop and implement regulatory strategies that meet regional requirements for any regulatory activities, while identifying the most efficient approval pathways by leveraging LRR or RPR local inputs.
• Contribute to RST activities and support the development of Global Regulatory Strategy, including planning and preparation of projects or response for complex scientific questions that require 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 (LRR), Regulatory Partner Representatives (RPR), 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 (e.g. rare diseases, orphan drugs, toll manufacturing, reliance pathways)
• 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.

Your Profile

• A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous
• At least 5 years of regulatory experience within the international markets, supported by additional pharmaceutical /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.

Why Join Us?

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.