Government Affairs Strategist
7 days ago
At F. Hoffmann-La Roche Gruppe, we foster a culture of diversity, equity, and inclusion to better serve the communities we care about. To succeed in healthcare on a global scale, understanding diverse needs is crucial.
The RoleA healthier future drives our pursuit of innovation. We continuously advance science to ensure everyone has access to necessary healthcare today and tomorrow. Creating a world where people have more time with loved ones – that's what makes us Roche.
We're looking for a Government, Quality & Regulatory Affairs Leader, reporting to the Country Manager, who sits in the Leadership Team. This role will work as the Affiliate Government Affairs (GA), Quality Head (AQH), and Deputy Local Safety Officer (LSO)/ Local Regulatory Safety Officer (LRSO) of the Philippines. You'll interface with the Regional / Global QRA team and engage proactively with external and internal stakeholders. In this position, you'll lead, manage, and oversee the Government, Quality, and Regulatory Affairs function and teams. You'll develop strategic objectives to achieve excellence in quality and regulatory management and work with external stakeholders to enable interactions and working agreements with Government Officials, Public Institutions, Trade Organizations, NGOs, Foreign Chambers, etc.
Key Responsibilities:
- Quality Affairs Lead: Maintain an effective quality management system and governance for the Philippines. Continuously improve governance to meet business and compliance needs. Oversee and ensure timely completion of internal and external audits and post-auditing activities to address audit findings. Ensure affiliate operations comply with regulatory requirements and Roche corporate standards. Communicate 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.
- Deputy Local Safety Officer: Support the LSO for DIA in performing their duties with regards to Safety Board/ Recalls and Customer Notifications and Complaints.
- Regulatory Affairs Lead: Ensure Roche products meet local, regional, and global regulations, Roche corporate standards, and expectations. Prepare for and manage health authority inspections by ensuring the affiliate operates in an 'inspection-ready' manner at all times. Prepare adequate and timely responses to any inspection observations and implement appropriate corrections, as necessary. Lead and oversee development and execution of regulatory strategies, projects, submissions, and associated activities to ensure rapid and optimal registration for all new products and indications, line extensions, and the effective maintenance of existing products. Interact with local health authorities and international health authorities. Develop and cultivate external relationships with health authorities and other stakeholders or influencers. Ensure regulatory activities result in the timely approval and broadest use of products for the assigned affiliate. Ensure affiliate alignment with regional and global regulatory direction and guidance. Ensure timely, accurate, and compliant regulatory documentation, standards, systems, and procedures across the affiliate.
- Government Affairs Lead: Develop and implement an 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. Undertake precise market landscaping activities; identify and engage with appropriate external partners such as government officials, patient organizations, policy influencers, and trade organizations; and collaborate with the internal team to establish opportunities to explore value-based healthcare potential.
About You:
- 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.
Learn more about Roche.
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Taguig, National Capital Region, Philippines F. Hoffmann-La Roche Gruppe Full timeRoche 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,...
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Taguig, National Capital Region, Philippines F. Hoffmann-La Roche Gruppe Full timeRoche 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,...
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