Director Regulatory Affairs China Hong Kong Japan H/F Servier

Mission :

Accountable for the elaboration of the regional regulatory strategy and registration processes in Countries under his/her responsibility by respecting the defined schedules and by assisting his/her staff.

Propose and implement all required actions for the maintenance of quality standards in regulatory affairs activities, by continuous oversight on regulatory requirements.

Lead, manage, develop and motivate the Regulatory Team (RRL), to include annual performance appraisals and objective setting.

Ensure the implementation and development of skills, knowledge (e.g. country regulation, SOP e-learning...) and tools to enable members from the Department to achieve their objectives.

Activities & Responsibilities :

Regional requirements in development plan:

- Accountable for regional regulatory strategy inputs (e.g. regional specific guidelines, need of ethnic sensitivity data, ...).
- Ensure that RRL from her/his team well define and explain the regional regulatory requirements to the GRT (e.g. clinical data requirements, Regulatory Authority consultation needs & timing).

Regulatory Authorities (RA) consultations:

- Support the RRL for the consolidation and validation of the regional requirements, to advise the GRL with national requirements and adapt the reference Briefing Book or adapted documentation.
- Support RRL for Leading the preparation of the meeting with Regulatory Authorities (coordinate organization, rehearsals) and participate to the meeting if needed.

Registration file procedure, commitments and LCM:

- Accountable for Marketing Authorization granting and lifecycle maintenance
- Support her/his team for the preparation of answers to Regulatory Authorities' questions.
- Ensure her/his team provide comprehensive explanation of the Regulatory Authorities' question/position to relevant stakeholders.
- Ensure the submission of the validated regulatory and scientific documentation to Regulatory Authorities in accordance with the regulatory requirements
- Follow-up of the regulatory commitments in the concerned country.
- Ensure her/his team maintain awareness of regulatory focused intelligence, including regulatory precedents for the concerned countries.
- Lead and support activities to ensure an efficient implementation of the regulatory strategy for existing assets and commercial products.

Internal communication

- Facilitate interactions between local and Headquarter teams
- Ensure a good collaboration with internal stakeholders and attend meetings to support the team when necessary
- Ensure that her/his team support and accompany the LRA (e.g. sharing information, routine zone meetings, ...).
- Ensure that relevant information is shared among the RRL in the team (teams meeting,...)

Qualifications

- Knowledge of national legislation and regulations related to medicinal products concerning the dedicated region
- Awareness of the regulatory procedures in the region for scientific Advice/ Authority consultation , registration, post approval changes, extensions and renewals
- Knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Knowledge of drug development
- Regulatory submissions experience
- Working with policies and procedures
- Experience interacting with Regulatory Authorities
- Communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across concerned regional countries and international borders

Profile :

- Bachelor's degree or equivalent experience with M/S, Pharm D, PhD/MD.
- Master's degree and at least 5 years of experience in regulatory or pharmaceutical drug development.

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