Job Description

As the Head for Regulatory Affairs, the role will have oversight of regulatory activities in countries within Asia & Eurasia Zone and is the Business Partner to General Medicines, Vaccines and Specialty care Global Business Units.

He/ She will collaborate with International Country Management, Regulatory Transformation, International Product Lead for the development of regulatory strategy.

This role will lead the Asia RA teams to ensure regulatory plans are implemented in the countries.

Key Accountabilities:

• Work in collaboration with International Product Leaders and Asia Countries Regulatory Affairs head for development of regional product and labeling submission strategy

• Liaise with Commercial and provide Regulatory input to Global Regulatory Affairs on local RA strategy

• Coordination of regulatory activities between source contact & RA Affiliates to ensure availability of the dossier / additional data and find appropriate ways to facilitate and accelerate product registration.

• Support development and implementation of standard operating procedures and systems and tools related to regulatory affairs

• Provide effective communication to functional, regional organizations and project team members. Take decisions based on advanced predictive models
  

Drive Innovation:

• Ensure adequate process flow for the innovation dossiers to support regional business goals, optimum yearly targets and registration plans.

• Interact with and support Business Unit management, sales & medico-marketing group for the preparation of market plans and direction to be undertaken by Headquarters.

• Ability to provide input, guidance and recommendations in the preparation of the dossiers from different sources to give uniformity of filing in each country.

• Provide Regulatory expertise on external growth opportunities (Due Diligences) and for each project ensure adequate regulatory resources for dossier assessment, coordinate regulatory activities with RA Affiliates, source contact and other relevant functions. Delivering regulatory solutions through digital and data driven frameworks
  

Business Partnership:

• Identify and work closely with internal and external experts to achieve optimal outcomes.

• Develop strong partnership with other departments to implement Business Strategy i.e.: Public Affairs, Industrial Affairs, Business Development, Legal, Finance, Medical, Pharmacovigilance, supply chain, marketing, etc.

Clear updates to International Region Head of Regulatory risks, opportunities, and internal/external emerging topics. In collaboration with International CMO, ensure appropriate planning and tracking of submissions by RA Affiliates / estimated & effective approval dates

Ensure Full Compliance of Portfolio:

• Become an expert of Asia regulatory requirements and provide clear guidance to company stakeholders related to any potential impact on product registration and maintenance.

• Ensure compliance and license to operate for all Asia portfolio (current and innovation)

Identify regulatory issues and ensure resolution in a timely fashion with adequate planning.

External Environment Shaping:

• Internal and external influencing to shape regulatory environment of the future

• Forceful representative of Sanofi in front of governmental agencies

• Constructive partner with the agencies to push for simplification and harmonization

• Prepare the company for future regulatory environment changes

Lead discussion to optimize regulatory pathways and accelerate access to medicines

People & Talent Development:

• Prepare people for the future culture in term of accountabilities

• Empower the team to take more responsibilities

• Develop collaborative and strategic mindset within the team

Lead attractiveness of the regulatory affairs organization in Asia for Sanofi talents

Budget Management:

In charge of management of the budget for Asia Regulatory Affairs team

The major challenges of this role are:

• To lead the regulatory strategy of very diverse markets and Regulatory Environment

• To ensure new registration, renewal and life cycle maintenance of large and diverse portfolio of pharmaceutical products

• To develop mitigation plan to adapt to unpredictable changes of regulatory environment

To ensure full compliance of a huge portfolio of licenses within fast evolving regulatory environment

Experience

• At least 5-8 years of experience including internships in regulatory CMC/ Regulatory affairs in regulated or lesser regulated markets.

• Prior experience in Asia & Eurasia regulatory affairs would be an advantage.

Education

• Degree in Pharmaceutical Sciences/ Life Sciences/ Bio-medical sciences (Candidates with Bachelor’s degree in the other disciplines may also be considered provided they have relevant working experience)

Competencies

• Ability to lead and develop teams.

• Strong interpersonal and communication skills (writing & verbal) with excellent command of English. Competency in 1 other language would be an added advantage.

• Ability to collaborate in a matrix organization.

• Strong cultural awareness

• Familiar with project development through cross- functional activities.

• Ability to establish and maintain good regulatory networking internally and externally.

• Highly self-motivated, proactive and good sense of responsibility.

• Strong organizational and influencing skills.

• Well-organised with good sense of responsibility.

• High influencing skills

• Computer skills: Word, Excel, On-line (Quest 2) Registration.