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Regulatory and Quality Management Leader

2 weeks ago

Taguig, National Capital Region, Philippines F. Hoffmann-La Roche Gruppe Full time

F. Hoffmann-La Roche Gruppe prioritizes diversity, equity, and inclusion to better serve the communities we care about. Our mission is to innovate and advance science to ensure everyone has access to necessary healthcare today and tomorrow.

The Position

We're seeking a Government, Quality & Regulatory Affairs Leader who will lead, manage, and oversee the Government, Quality, and Regulatory Affairs function and teams. This role will work closely with the Regional / Global QRA team and engage proactively with external and internal stakeholders to develop strategic objectives and achieve excellence in quality and regulatory management.

Responsibilities:

  1. Quality Affairs Lead: Establish and maintain an effective quality management system and governance for the Philippines. Collaborate with affiliate operations to ensure compliance with regulatory requirements and Roche corporate standards. Communicate significant quality or regulatory issues and risks to affiliate management.
  2. Deputy Local Safety Officer: Support the LSO for DIA in managing safety board/recalls and customer notifications/complaints.
  3. Regulatory Affairs Lead: Ensure Roche products meet local, regional, and global regulations, Roche corporate standards, and expectations. Prepare for and manage health authority inspections. Develop and execute regulatory strategies, projects, submissions, and associated activities to ensure rapid and optimal registration for new products and indications, line extensions, and the effective maintenance of existing products.
  4. Government Affairs Lead: Develop and implement an integrated government stakeholder engagement strategy. Collaborate with internal departments to establish opportunities to explore value-based healthcare potential.

Your Background:

  • Bachelor/Master degree in Pharmaceutical or Science-related field (preferably medical laboratory-related), MBA qualification would be an advantage.
  • At least 8 years of people management/leadership experience in regulatory affairs in a IVD/Medical Devices/Pharmaceutical Company, with strong Quality Assurance and good Government affairs experience.
  • Previous work at a government agency such as DOH, FDA, or others and/or at a trade organization such as ECCP or AmCham is highly desirable.
  • Proficient in both English and Filipino (written & spoken) and possesses strong presentation/facilitation skills.
  • Strong analytical skills and able to manage complex regulatory issues.
  • Good project management skills and able to develop, drive, and deliver strategic goals.
  • Strong and effective communicator who can challenge status quo and ask questions.
  • Able to develop and maintain a good network across multiple levels within the organization as well as externally.
  • Able to influence, manage, and make sound recommendations to all stakeholders.
  • Able to think and plan strategically.

Visit Roche to learn more.