Government, Regulatory, and Quality Affairs Leader

4 days ago

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

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

A healthier future. It is what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That is what makes us Roche.

Roche Diagnostics Philippines is looking for a Government, Quality & Regulatory Affairs Leader, reporting to the Country Manager who sits in the Leadership Team. The role works as the Affiliate Government Affairs (GA), Quality Head (AQH), and Deputy Local Safety Officer (LSO)/ Local Regulatory Safety Officer (LRSO) of the Philippines and serves as interface with the Regional / Global QRA team and proactively engages with external and internal stakeholders. In this position, you will lead, manage and oversee the Government, Quality and Regulatory Affairs function and teams and develop strategic objectives to achieve excellence in quality and regulatory management, as well as work with external stakeholders to enable the interaction and working agreements with Government Officials, Public Institutions, Trade Organizations, NGOs, Foreign Chambers, etc.

Key responsibilities include:

  1. Quality Affairs Lead: Helps maintain an effective quality management system and governance for the Philippines, and continually improves the governance to meet business and compliance needs. Oversees and ensures timely and appropriate completion of internal and external audits and post-auditing activities to address audit findings. Ensures that affiliate operations, including product, other materials and operations, comply with regulatory requirements and Roche corporate standards. Communicates significant quality or regulatory issues and risks in a timely manner that may impact operations, product quality or regulatory compliance to affiliate management. Responsible for compliance with GMP-requirements.
  2. Deputy Local Safety Officer: Supports the LSO for DIA in performing their duties with regards to Safety Board/ Recalls and Customer Notifications and Complaints.
  3. Regulatory Affairs Lead: Helps ensure Roche products meet local, regional and global regulations, Roche corporate standards and expectations. Prepares for and manages health authority inspections by assuring the affiliate is operating in an "inspection ready" manner at all times. Prepares adequate and timely responses to any inspection observations and implements appropriate and thorough corrections, as necessary. Leads and oversees development and execution of regulatory strategies, regulatory projects, regulatory submissions and associated activities to ensure rapid and optimal registration for all new products and indications, as well as line extensions and ensuring the effective and compliant regulatory maintenance of existing products. Interacts with local health authorities, and may have interactions with international health authorities. With team, develops and cultivates external relationships, such as with health authorities and other stakeholders or influencers. Ensures regulatory activities result in the timely approval and broadest use of products for the assigned affiliate. Ensures affiliate alignment with regional and global regulatory direction and guidance. Ensures timely, accurate and compliant regulatory documentation, standards, systems and procedures across the affiliate.
  4. Government Affairs Lead: Leads the development and implementation of integrated government stakeholder engagement strategy based on a thorough understanding of the relevant healthcare landscape through collaboration with internal departments such as medical, marketing, sales, and market access. Undertakes precise market landscaping activities; identifies and engages with appropriate external partners such as government officials, patient organisations, policy influencers and trade organisations; and collaborates with the internal team (e.g., business development, sales) to establish opportunities to explore value based healthcare potential.

Who You Are:

  • 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 asks 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 https://www.roche.com/careers.htm to learn more about Roche.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

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