# Regulatory Group Director, International/APAC at Roche

Roche is hiring a Regulatory Group Director, International/APAC. Level rates it Little AI ●○○○; you can [apply on Roche](https://jobsbylevel.com/go/ff5cf3bc-c855-4232-bb00-56fc0777b2bf?utm_medium=ai-agent).

AI Level 1, AI centrality 38 out of 100. Central Singapore.

## Details

- Company: [Roche](https://jobsbylevel.com/companies/roche)
- AI level: AI Level 1 (score 38 out of 100)
- Location: Central Singapore
- Posted: November 9, 2026
- Apply: https://jobsbylevel.com/go/ff5cf3bc-c855-4232-bb00-56fc0777b2bf?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=regulatory-group-director-international-apac-at-roche-5d5da1

## 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. The Position Regulatory Group Director, International/APAC 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. 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

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/regulatory-group-director-international-apac-at-roche-5d5da1

Source: https://jobsbylevel.com/jobs/regulatory-group-director-international-apac-at-roche-5d5da1

## Cite this page

Level. https://jobsbylevel.com/jobs/regulatory-group-director-international-apac-at-roche-5d5da1.

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