Regulatory Affairs Lead — Roche

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At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As the most senior member in the team, set strategy and priorities for the team, allocate resources accordingly, provide coaching and mentorship to the team members and represent the team internally and externally or otherwise delegate as appropriate. Orchestrate and oversee pre-launch registration strategies and lead the co-creation of launch readiness in collaboration with respective pods Oversee and manage all Regulatory Affairs work of the Affiliate; oversee external parties, such as distributors, agents, etc. if applicable. Drive continuous process optimization in the Regulatory Affairs area, with an aim to improve efficiency as well as compliance Engage Health Authorities, government bodies, as well as pharmaceutical industry associations in shaping regulatory policies and environment towards continuous improvement in addressing unmet medical needs for patients. All Roche employees are expected to practice high standards of compliance with both external and internal policies and regulations as well as participate and be involved in SHE initiatives within the Company. Responsibilities and Accountabilities

• Regulatory Strategy & Influence: Develop and implement innovative, risk-based regulatory strategies for all affiliate products to accelerate access, and lead/influence the development of global regulatory strategies, considering local regulations and business needs.
• Filings and Submissions: Lead strategic oversight of all regulatory filing activities across product life cycles, ensuring timely regulatory submissions and approvals for new products, line extensions, and maintenance updates, aligned with commercial and supply continuity.
• Stakeholder Relations: Build trusted partnerships by leading contacts and negotiations with local Healthcare Authorities (HAs) and internal stakeholders, influencing for successful regulatory outcomes, and communicating filing statuses.
• Regulatory Compliance & Inspection Readiness: Ensure all Affiliate regulatory activities comply with Roche global standards and local regulations, maintain current knowledge of practices and standards, and ensure the Affiliate is prepared for regulatory inspections and audits.
• Leadership and Team Management: As the senior team member, set the team's strategy and priorities, allocate resources, provide coaching and mentorship, and assist in recruiting and retaining talent.
• Regulatory Intelligence and Policy Shaping: Own the gathering and dissemination of regulatory intelligence for the Affiliate, and actively shape the regulatory environment through leadership roles in industry associations.
• Product and Documentation Support: Oversee end-to-end local product packaging and labeling, act as the Company Pharmacist for specific compliance (e.g., Poison/Psychotropic License), support local market access, and ensure affiliate regulatory documentation is maintained and archived compliantly. Requirements:
• Experience: Minimum of 5 years in a regulatory affairs role within a pharmaceutical environment.
• Training: Trained in Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements for pharmaceuticals.
• Education and Accreditation: Possesses a Degree in Pharmacy, accredited by the relevant authority with the Ministry of Health, Malaysia, and is eligible to hold necessary pharmaceutical licenses.
• Regulatory Knowledge: Knowledgeable in pharmaceutical regulations and registration requirements in Malaysia.
• Language and Computer Skills: Fluent in w