Regulatory Affairs Partner - Roche Pharmaceuticals
The Position
At Roche, we are committed to innovation, learning, and growing to improve patient outcomes. As a Regulatory Affairs Partner, you will work closely with the team to navigate the evolving regulatory landscape in Hong Kong, Macau, and the Greater Bay Area. Your role will involve the strategic and tactical execution of regulatory submissions, ensuring compliance, and driving value for patients. This role plays a vital part in supporting Roche’s mission to deliver healthcare innovations that make a significant impact on patients' lives.
Key Responsibilities
Regulatory Strategy Development: Lead and drive the regulatory strategy for Roche’s strategic and established product portfolios.
Regulatory Submissions: Manage the preparation and submission of high-quality, timely regulatory documents for product approvals, including NCEs, import licenses to Macau, and applications to the Greater Bay Area.
Regulatory Compliance: Ensure that all regulatory activities are executed in compliance with company policies and regulatory requirements.
Collaboration: Contribute to the License to Operate team’s objectives and work packages, ensuring alignment with Roche’s strategic goals.
Regulatory System Shaping: Advocate for a patient-centric regulatory environment, contributing to the shaping of Roche’s regulatory strategy.
Labeling Compliance: Maintain procedures to ensure that labeling for secondary packaging products is compliant with local regulations.
Ad-hoc Duties: Perform other tasks as assigned by the License to Operate Lead.
Who You Are
Qualifications:
2 years of experience in Hong Kong drug regulatory affairs (RA executive or Assistant RA manager level).
Bachelor’s degree or above in a Science-related discipline.
Capabilities:
Ability to work cross-functionally at the local and global levels, serving as Roche’s primary contact with the HK Drug Office.
Strong negotiation and influencing skills with external stakeholders.
Entrepreneurial mindset to identify opportunities while maintaining regulatory compliance.
Expertise in navigating complex regulatory issues and collaborating to solve them.
A strong problem-solver, thriving in a high-performance environment with attention to detail and accuracy.
Mindset & Behaviors:
Embrace Roche’s values of Integrity, Courage, and Passion.
Demonstrate leadership behaviors in line with Roche’s core competencies (VACC: visionary, architect, coach, catalyst).
Ability to learn quickly, take risks, and experiment.
Drive digital transformation to create value and impact across healthcare ecosystems.
Think from an enterprise perspective, transcending boundaries for the greater good of healthcare.
Embrace agile working methodologies to contribute to Roche’s transformational journey.
Who We Are
Roche is a global leader in healthcare, with over 100,000 employees dedicated to advancing science and improving patient outcomes. Together, we are committed to building a healthier future by making life-changing healthcare solutions accessible worldwide. We empower our employees to explore new possibilities, foster creativity, and contribute to meaningful work that impacts millions of lives.
Equal Opportunity Employer
Roche is an Equal Opportunity Employer and embraces diversity in the workplace. We strive to ensure that everyone has access to equal opportunities for employment and career growth.
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