Head of Regulatory Affairs Cluster Lead

JOB SUMMARY:
Summarize the primary purpose & key accountabilities of the job.
- Primary GRA-I Asia Point of Contact and leader of strategic teams and initiatives in a cluster for GRA-I Asia
- Member and strategic contributor to Regional Biopharma BU Leadership Team and Regional GRA-I Asia RA

Leadership Team (GRA-I Asia RALT Team)
- In addition to in-country leadership for Regulatory Affairs team in the cluster, the role also oversees and provide leadership, strategic direction and oversight of the cluster, including management of Regulatory Country Heads in the cluster, specific to the

Biopharma BU.
- To interface with other functional leads (e.g. GCMC, Regional hubs, PGS, Commercial, Medical) to ensure

collaborative connectivity with these key stakeholders, and a more focused regional RA approach to supporting

country and regional business objectives and ensure product access.
- Deliver innovative and beneficial pharmaceutical products with competitive labelling to the region in timely

manner.
- Be a recognised partner for other focused business activities and initiatives and with internal groups that

contribute to regulatory success.

RESPONSIBILITIES:

- Lead and manage the local RA team and other RA teams in the cluster the development of regulatory strategies to support

management. Ensure that regional RA teams provide strategic regulatory input into GRA global regulatory

strategies, thus providing optimal support for meeting local business objectives.
- Develop strong partnerships with in-country and regional teams (e.g. Country Managers, Medical, Marketing,

Supply Chain, Regional hubs etc) and above country Therapeutic Area and Regional Teams to facilitate the

development and implementation of registration strategies to expedite the registration of new products, line

extensions and life-cycle optimization.
- Provide strategic contribution to the GRA-I Asia leadership.
- Responsible for the development, leadership and performance management of direct reports team to achieve

company objectives. Develop and enhance the capabilities and capacities of the RA teams through the

identification and implementation of training and development needs.
- Responsible for developing and supporting relationships with key external agencies (HA, Trade associations, RKOL

etc.). Support the HA interface throughout the development and lifecycle of a product. Support long-term and

positive relationship characterized by integrity, quality, compliance and leadership.
- Active participation in regional trade organization and effective communication to key stakeholders of key issues

that could impact regulatory strategies or the business. Understand regional regulations and developing trends in

the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory

intelligence / landscape knowledge to support the development and implementation of regulatory and business

strategies, and decision making.
- Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate

regulatory processes, SOP’s and systems (e.g. CMC change control, product labelling, etc.) are in place, and that

the RA staff (permanent and contract) are properly trained in these systems and procedures.
- Oversee and manage the completion of NDA and Lifecycle (LC) submissions and approvals as per established GRAI

performance metrics.
- Responsible for ensuring that all regulatory activities are compliant with local regulations, requirements and

practices.
- Contribute to regional change management and continuous improvement projects.

People Management:

- Foster continual learning to promote regulatory excellence.
- Manage the performance of direct reports to achieve agreed objectives.
- Identify and address training and developments needs to encourage talent development and succession planning.
- Keep team continuously engaged to retain/attract talent.

Project Management:

- Oversee and/or facilitate strategic process improvements initiatives.
- Ensure product strategies, submission and approval time lines.

QUALIFICATIONS / SKILLS:

- Scientific degree (preferably a pharmacist). A higher degree (MS or PhD) may be an advantage
- Pharmacist degree may be mandatory in some countries
- Appropriate Regulatory Affairs experience - minimum 10 years
- Management Degree (Undergraduate or MBA) may be an advantage
- Proven ability to consistently deliver to time, cost and quality standards.
- Fluent in English - written and spoken communication skills
- Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with

proven examples of contribution.
- Proven ability to manage complex regulatory issues.
- Proven ability to consistently deliver to time, cost and quality standards in a complex matrix environment.
- Regional regulatory experience including knowledge of CTA’s and NDA submission processes and product life