Regulatory Affairs Sub-Region Head Asia Pacific

24 hours ago

Singapore NOVARTIS ASIA PACIFIC PHARMACEUTICALS PTE. LTD. Full time
About the Role:

As the Regulatory Affairs Sub-Region Head for Asia Pacific, you will play a critical role in ensuring the development and registration of global and regional projects/brands meet their milestones, and functional excellence is achieved. You will drive the development of registration strategies, including lifecycle management, for the region in close collaboration with RA Country Heads, Regional New Product Strategy, Global RA organization, and commercial stakeholders in the sub-region. Your expertise will be instrumental in translating regulatory policy into tangible regulatory strategies, including the management of external stakeholders. In collaboration with the RA Region Head, you will drive collaborative, enterprise thinking, and cross-functional collaboration at the sub-region and country level.

Key Responsibilities:
  • Product Registration and Key Life-Cycle Management: You will set up development and registration objectives with country RA teams in alignment with RA Region Head and Commercial teams' objectives in the geographic area of responsibility. You will be accountable for setting optimal regulatory strategy and driving the execution of the strategy in the geographic area of responsibility during product development and registration phase.
  • Product Registration and Key Life-Cycle Management: You will ensure optimal use of regulatory strategic opportunities by country RA teams to ensure acceleration of priority products during filing and registration. You will participate in Launch Readiness Reviews and provide strategic regulatory input for key markets in the geographic area of responsibility, as required. You will partner with Regional New Product Strategy, GPRDs, GTALs, and RA Country Heads to ensure effective resolution of regulatory strategic differences/issues between GPTs and regional commercial management.
  • Functional Excellence: You will drive regional functional expertise and be accountable for the implementation of RA functional excellence activities in the assigned countries in line with global RA guidance or strategy. You will be accountable for the implementation of compliance activities and associated processes by country RA teams.
  • Functional Excellence: You will provide strategic guidance and support to RA Country Heads. You will ensure alignment with RA Region Head appropriate level of RA resources in countries of assigned geographic area. You will set up and implement optimal systems/collaborations for the exchange of best practice(s) across the country RA teams, working in close partnership with other RA Sub-Region heads.
  • External Focus: You will translate regulatory intelligence in the assigned countries into tangible regulatory strategy for Novartis Portfolio in cooperation with country RA teams and global or regional RA policy roles. You will shape the regulatory environment by active participation at relevant HA meetings, including influencing and negotiations in alignment with country RA teams and Global Development Strategy.
  • External Focus: You will represent Novartis on the appropriate international trade association(s) and relevant external forums to leverage and shape regional regulatory guidelines and standards for the Novartis Portfolio. You will ensure budget targets are met and provide input into RA budgets in the geographical area of responsibility.
  • People: You will partner with appropriate stakeholders to drive effective hiring, development, and training of RA Country heads and associates in line with Global/regional RA vision. You will drive the RA OTR discussions for the cluster. You will be responsible for the development of RA country Heads. You will coach and mentor RA country Heads as appropriate.
Essential Requirements:
  • Master in Life Sciences degree. PhD or Higher Degree or equivalent experience desirable.
  • Minimum 7-10 years' experience in drug development and registration at global or country level.
  • Experience with countries in Asia Pacific will be an advantage. Excellent inter-personal skills.
  • Proven strong leadership skills. Experience leading leaders will be an advantage. Ability to develop and communicate strategic vision.
  • In-depth understanding of the regulations and pharmaceutical business models in assigned region, awareness of regulations in other major regions (e.g. EU, US). Shows cultural awareness.
  • Ability to work in a cross-functional environment. Highly committed and team-oriented.
  • Excellent communication and negotiation skills. Proven track record of HA negotiations.
  • Ability to travel and represent the organization.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people's lives, and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us.

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here.

Video: Novartis Research & Development team, on Innovation at Novartis - YouTube

Tell employers what skills you have

Negotiation
Drug Development
Commercial Management
Budgets
Interpersonal Skills
Regulatory Affairs
Medicine
Regulatory Strategy
Translation
Strategy
Trade Associations
Compliance
Product Development
Life Sciences
International Trade

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