Regulatory Group Director, International/APAC

Roche; Singapore; On-site; SGD 260,000 - 480,000; Full time

Job summary

Roche in Singapore seeks a senior leader to head the PTR International team, guiding regulatory CMC submissions across APAC. You will recruit, develop, and manage talent while aligning local filings with global plans to accelerate patient access.

You will drive strategic regulatory programs, liaise with health authorities, and collaborate with commercial, medical, and manufacturing teams to shape portfolio strategies and ensure continuous supply of compliant medicines.

Qualifications

• Education PhD/MC degree in science or related area is required.
• 15+ years of experience in the pharmaceutical industry; line management experience is an asset.

Responsibilities

• Lead a PTR International team managing regulatory CMC submissions.
• Develop and implement end-to-end regulatory filing strategies aligned with global plans.
• Coordinate with global PTR Leaders and local/regional affiliates to ensure timely submissions.
• Collaborate with Regulatory, Commercial, Medical Affairs, and Supply Chain to support market access and continuous supply of compliant products.

Skills

PTR Competencies

Regulatory strategy

Problem solving

Interpersonal skills

Stakeholder negotiation

Influence & independence

Team collaboration

Time zone flexibility

Languages

Education

PhD/MC in science

Job description

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.

Position Summary

This position leads a PTR team, in the APAC region, responsible for management of regulatory CMC submissions for all Roche products. The team shall develop and implement robust end to end strategies of the local filings based on global development plan, global/regional/local business priorities, local regulatory requirements and landscape to accelerate drug access to the patients by ensuring right first-time submissions to Health Authorities.

Responsibilities

Your opportunity People Management Recruit, onboard, train, develop and retain talent on the PTR International team. Ensure appropriate Regulatory Affairs resources and budgets are in place. Lead a team of professionals responsible for regional/local management of regulatory submissions with diversified local regulatory requirements and business priorities. Regulatory submissions in scope include new drug registrations (NDA/BLA), line extensions (LE), post-approval submissions/variations (PAS), renewals and annual reports, for pharmaceutical small molecules and biological products. Regulatory Submissions Drive acceleration of the innovative products registration and ensure continuous supply of the compliant products to the patients through establishing a network and relationship with DRA Affiliates, Agents and Distributors, if applicable. With your team, develop and maintain up-to-date regulatory knowledge repository including local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards. Facilitate and promote timely updates and maintenance of CMC change management in alignment with the regulatory information submitted to / approved by externally Health Authority or internally by the appropriate functional area. In cooperation with global PTR Technical Regulatory Leaders and Technical Regulatory Teams, lead, influence and contribute to innovative regulatory strategies utilizing country requirements knowledge, understanding of the local regulatory challenges and opportunities, and applying risk based principles to balance regulatory compliance and business/supply needs to maximize efficiency, quality and rate of submission approvals by Health Authorities. Provide global and regional Regulatory Affairs input and guidance into local Affiliate business strategies (e.g. drug portfolio shaping, market access, medical affairs, technical assessments, technical agreements, local manufacturing/packaging activities, etc.) In coordination with Affiliates DRA, act as direct liaison and CMC contact SME with regulatory authorities to facilitate the prompt review and approval of submissions. Stakeholders Management Collaborate with Regional Commercial, Medical Affairs, Supply Chain, Pharma Development Regulatory on strategic regional priorities aligned with the global business objectives. To build, maintain and promote the partnership with the regional and local commercial organizations to further accelerate regulatory approvals and secure continuous availability of the innovative products to the patients. To partnership with PDR ERAS counterpart to provide one unified regulatory voice toward affiliates, PTR/PDR management and regional functions for regulatory topics relating to International Markets and to ensure aligned strategic regulatory contribution to the key initiatives/projects for the region. Sponsor, lead and contribute to global and regional projects and initiatives involving International Markets aimed to accelerate launches of the Roche products and to ensure availability of regulatory compliant products to the patients.

Candidate Profile

Education PhD/MC degree in science or related area is required. Experience At least 15 years of experience in the pharmaceutical industry, line management experience is an asset. Industry recognized leader in the Regulatory Affairs / CMC field with significant experience in International Markets. Strong proven experience in Regulatory Affairs, CMC requirements for small molecule/biologic products, development, manufacturing and/or quality assurance.

Knowledge/Skills/Competencies

• Demonstrates, or has proven abilities to demonstrate PTR and Roche Core Competencies.
• Ability to demonstrate Roche Values and Leadership Commitments.
• Demonstrates effective problem solving, strong understanding of regulatory strategies, excellent interpersonal skills and the ability to prioritize multiple tasks.
• Proven ability to lead successful negotiations with the internal and external stakeholders including Governance Bodies and consistently demonstrates efficient influential skills.
• Proven ability to influence and work both independently and collaboratively in a team structure.
• Strong team work ethics and experience to motivate team members. Ability to work across various time zones. Very high level of professionalism, efficiency, and follow-through. Ideally fluent in 1-2 languages spoken in the region of responsibility, in addition to English.

Travel requirement

Ability to travel up to 20%

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.