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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 accelerate launches of the Roche products and to ensure availability of regulatory compliant products to the patients.
Who you are
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.
