Pascale Jean

About Me

Hello, I’m Pascale; a seasoned Regulatory Affairs and Pharmacovigilance leader with 20 years of experience in the pharmaceutical industry, dedicated to ensuring that innovative therapies are delivered safely and effectively to patients worldwide.
My diverse experiences led me to lead and manage multiple global submissions in Regulatory Affairs and Pharmacovigilance, collaborating with cross-functional teams to balance scientific innovation with patient safety. I thrive on building strong partnerships, mentoring others, and navigating complex challenges with clarity and purpose. With a particular interest in advancing therapies in women’s health and family well-being, I am committed to work that makes a meaningful impact. Beyond my career, I value community and service, dedicating time to volunteer work that reflects my belief in contributing positively both professionally and personally.
Resume

Work experiences

Novartis Pharmaceuticals (Aug. 2016 - Dec. 2024)
Global RMP Manager/Lead
  • Led development and execution of 20+ global Risk Management Plans (RMPs) and 4 U.S. REMS programs for flagship therapies including Kymriah, Scemblix, and Tasigna, securing timely approvals across FDA, EMA, and Health Canada.
  • Directed the preparation and submission of 30+ PSURs and DSURs annually, enhancing data integration and cross-functional review processes, which reduced regulatory feedback cycles by 25% and improved inspection readiness.
  • Chaired global safety governance teams of 15–20 cross-functional stakeholders, achieving alignment on complex risk minimization strategies that supported the successful launch and lifecycle management of high-priority therapies.
  • Resolved over 35 critical regulatory authority queries (FDA, EMA, Health Canada) through proactive engagement, mitigating potential delays and reinforcing Novartis’ reputation for compliance and patient safety leadership.
Novartis Consumer Health (Jan 2014 - Feb 2016)
Category Regulatory Affairs Associate, Allergy and Decongestant
  • Led global submission strategy and renewals for respiratory products including Flonase, ensuring timely approvals across FDA, EMA, and Health Canada, and maintaining uninterrupted product availability in key markets.
  • Led global submission strategy and renewals for respiratory products including Flonase, ensuring timely approvals across FDA, EMA, and Health Canada, and maintaining uninterrupted product availability in key markets.
  • Streamlined submission processes by 20% through enhanced cross-functional coordination with CMC, Clinical, and Labeling teams, reducing rework and accelerating approval timelines.
  • Prepared high-quality regulatory dossiers and responses that successfully addressed authority queries, minimizing delays and strengthening GSK’s reputation with global health authorities.
Novartis Consumer Health (Aug 2010 - Dec 2013)
Global RA CMC Manager
  • Directed CMC regulatory submissions across EU, U.S., and ROW markets, ensuring timely approvals and maintaining compliance with EMA, FDA, and ICH guidelines for multiple therapeutic areas.
  • Strengthened CMC regulatory compliance by implementing improved documentation and change-control processes, reducing deficiencies in authority feedback by 30%.
  • Led CMC due diligence for product acquisitions and licensing opportunities, providing strategic regulatory assessments that supported successful business development decisions.
  • Oversaw regulatory strategy for medical device submissions and led audits with Notified Bodies, ensuring compliance with EU device regulations and securing approvals that expanded Novartis’ product portfolio.
Bayer Consumer Health (Sept 2007 - Aug 2010)
Global Project Leader
  • Led global CMC regulatory projects across multiple regions (EU, U.S., and ROW), ensuring timely submission and approval of variations, renewals, and post-approval changes in alignment with ICH and regional guidelines.
  • Provided regulatory intelligence monitoring for RA CMC leadership, analyzing evolving FDA, EMA, and ICH requirements, and delivering strategic insights that informed global submission strategies and compliance planning.
  • Coordinated cross-functional CMC teams, driving alignment between Regulatory Affairs, Quality, and Technical Development to resolve complex issues and accelerate product development milestones.
  • Enhanced CMC regulatory readiness by developing guidance tools and intelligence reports that strengthened decision-making for pipeline and marketed products.
Sanofi Aventis (Sep. 2006 - Sep. 2007)
Regulatory Affairs associate
  • Led global CMC regulatory projects across multiple regions (EU, U.S., and ROW), ensuring timely submission and approval of variations, renewals, and post-approval changes in alignment with ICH and regional guidelines.
  • Oversaw GxP audit readiness and regulatory alignment for new manufacturing sites, mitigating risks and ensuring successful inspections with no critical findings.
  • Directed marketing authorization (MA) renewals and post-approval variations, maintaining compliance with EMA, FDA, and ROW requirements while supporting lifecycle continuity.
  • Managed regulatory submissions for API supplier changes, ensuring smooth approval by health authorities and securing supply chain resilience for high-priority products.

Competencies

GLOBAL REGULATORY AFFAIRS SUBMISSION

As a seasoned regulatory affairs submission leader I support the development, testing, manufacturing, and marketing of healthcare products to provide the safest,
Learn More

PHARMACOVIGILANCE

Over the course of my career, I have developed comprehensive expertise in pharmacovigilance. 1 have led global projects, collaborated across functions, and delivered high-quality safety
Learn More

REGULATORY INTELLIGENCE

In my role leading Regulatory Intelligence, I managed the preparation and distribution of regulatory affairs newsletters, ensuring stakeholders received timely insights on evolving global regulations and policy
Learn More

PROJECT MANAGEMENT

With over 20 years of experience in the pharmaceutical industry and a Google Project Management Professional Certificate, I combine structured methodology with real-world leadership to deliver projects that
Learn More

Skills

  • Communication
  • Leadership
  • Collaboration
  • Time management
  • Creativity
  • Adaptability
  • Resilience
  • Decision making
  • Problem solving & conflict resolution
  • Analytical & critical thought
  • Negotiation & persuasion

Contact

Want to work with me? If you have a project or assignment where my skills could help, feel free to reach out. I’d be happy to explore it with you.
Scroll to Top