Job Description

The Position



Regulatory Affairs & Quality Lead, Roche Diagnostics Asia Pacific

Role Purpose:

As Regulatory Affairs & Quality Lead, you will play a critical role to develop, implement and continuous improve the APAC Q&R strategy across the APAC Region. You will provide leadership and consultation to the countries in regulatory matters, act as an interface with the Global Regulatory Affairs team and proactively engage with external stakeholders in collaboration with the Regulatory Policy Network lead for the APAC Region.

In this role, you will:

Be responsible for the development, implementation and continuous improvement of the APAC Regulatory Affairs & Quality (Q&R) strategy, to support and advise the APAC leadership team, Global Q&R leadership team and the APAC Q&R Affiliates Head to continuously drive business success with APAC Q&R insights/expertise.

Lead and oversee the APAC Q&R functional team for Roche Diagnostics and providing regulatory and quality leadership and strategic guidance to affiliate Q&R functions and teams in all Q&R-related matters - (supporting countries with adapting global regulatory strategies to local requirements).

Build effective and strong relationships with key stakeholders and senior management in global, regional and affiliates, with a special focus on proactive communication and co-creation of solutions for business critical challenges.

Identify gaps in critical cross-functional practices, and expertise required to drive business performance and work with Regional team to develop solutions and innovative initiatives.

Collaborate with the Regulatory Policy Network Lead for the APAC Region team to gather, assess, and disseminate regional APAC regional regulatory intelligence. closely align regional regulatory policy with global position and implementation accordingly.

Closely collaborate with the Regulatory Policy Network Lead for the APAC Region to build strong executive-level relationships with external partners including country/regional regulatory bodies, harmonization forums, industry organisations, trade organizations, regional coalitions and other stakeholder organizations, and actively lead in industry and regulatory or scientific task forces/working groups of importance to shape the regulatory landscape in line with Roche priorities and positions.

Actively engage with Global Quality and affiliates to enable successful implementation and sustainability of the Modular QMS.

Support the Community of Practices across Q&R in the region

Who you are:

Proven ability to establish and articulate a vision, set goals, develop and execute strategies, and track and measure results.

Proven experience working in teams through collaborative technological innovation in an agile environment or continuous improvement efforts that have yielded tangible results and/or positive impact for patients or business stakeholders.

Demonstrated success in establishing a high performing environment, catalyzing Roche Operating Principles, with an excellent reputation attracting the best talent and the commitment to developing and inspiring them.

Proven ability to create and sustain strong collaborative relationships and networks with diverse stakeholders across a complex global organization.

Intrapreneurial mindset with proven ability to incubate and foster agile organizations within a complex, global corporate environment.

Familiarity with the technological trends and their relevance to the healthcare industry. A passionate and decisive business leader. Demonstrating courage, vision and drive to achieve results at the forefront of innovative technological changes.

Qualification and Experience

University degree in relevant discipline required. A postgraduate degree (e.g. MSc or higher) in a relevant area would be desirable.

10+ years of Regulatory Affairs and/or Quality experience, operating in areas relevant to laboratory solutions and products aimed at the healthcare ecosystem.

Previous demonstrated success in the Regulatory arena and IVD field

5-7 years leading and managing teams

Proven experience negotiating with regulators/health authorties

Strong leadership experience, preferably with extensive experience of building and leading diverse teams, and/or matrix leadership of enterprise-level technology-based projects in relevant areas.

Proven ability to identify and mobilize resources, in a timely manner, that partner with value streams and others to achieve stated goals.

Highly developed leadership and people influencing skills in a matrixed environment, seeking to understand different perspectives and needs, gain broad partner buy-in, and co-create.

Demonstrated ability to proactively identify, develop and execute strategies to build competences to be future-ready and best-in-class.
Demonstrated ability to influence internal and external stakeholders with courageous authenticity and builds trust with individuals of all levels.

Ability to build and sustain strong collaborative relationships and networks with partners across a complex global organisation such as the Roche Diagnostics.

Able to foster positive partnerships through effective influencing, negotiation and conflict management skills. Ability to integrate your work in the context of wider strategic frameworks (e.g. other business unit strategies; enterprise-wide strategies, etc) and in a fast-moving and agile environment.

A strong and influential communicator, able to establish external partnerships with relevant partner organisations and stakeholders in the wider arena, and/or to act as an ambassador for Roche.
Ability to work independently and influence without authority.

Highly developed competencies in thinking strategically, analytically and innovatively. Able to quickly and creatively analyse situations and provide solutions to complex challenges.

A critical thinker who is able to analyse possibilities and solutions and make pragmatic trade-offs.

Location:

Preferred location will be Singapore, however other locations within Asia Pacific may also be considered.

APAC:

This is a diverse region culturally and with respect to business maturity. APAC Spirit is an embodiment of the organisation we in the APAC region aspire to be. As a member in this region, you will strive to deeply understand, live and encourage those around you to embrace the APAC Spirit principles.

As this position is a regional role, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities.

Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

Roche