Head of Regulatory Affairs

THE POSITION

Key responsibilities: 

  • Technical: Ensure quality control of the work according to the scope and in collaboration with the Operation Manager.

  • Control: respect of deadline and ensure the report will meet the client expectations in terms of quality, accuracy and compliance of the answer vs the request.

  • Performance: Implement & monitor KPIs to insure control of the quality, accuracy and respect of deadlines;

  • Operational: In charge to ensure the operational working flow till delivery of the work & payment of the invoice & allocation of working volume (within the internal and external team);

  • Managerial: Lead senior Regulatory team workflow. Manage the team of internal and external experts and ensure the recruitment, validation & contractual agreement with the HR manager & Technical Manager support, selection, technical validation, KPIs monitoring;

  • Process Implementation: a capability to build, implement and enforce new in Regulatory affairs compliance process;

  • Reporting: Will be involved in the reporting for full or sections of reports, presentations and other client deliverables in ensuring the regulatory compliance of product labeling, new product formulations and health and nutritional advertising. Will review the quality & technical content of the deliverable, control regularly the compliance of the answer provided with the regulation enforced it refers to. Would be in charge to coordinate also the proper answers on the additional questions (and validate it is still part of the initial scope or not);

  • Commercial: Direct interface with the client for the operational support and valid the technical aspect. Liaise with the commercial team to foresee the question of capability and capacity at contractual negotiation stage (ensure the additional workload could be covered within the contractual deadline) + ensure the translation from commercial contract to operational actions + could be also involved in presentations to client audiences via teleconference or in face-to-face meetings + support within the technical scope validation of each client request;

  • Communication/lobbing: Liaise with both internal and external regulatory stakeholders as per project requirements, participate in stakeholder’s engagement, helping network in Governmental agencies, Industry and Trade Association, Research Institutes

  • IT Development: Would be involved in the new IT/ AI development if RegASK Platform;

Key Competencies/ experiences:

Regulatory affairs experience > or = 8 years:

  • Proficiency in Food and/or Personal care Regulatory Affairs for Asia markets (Food Supplement, VMS, Cosmetic, Medical Device)

  • Significant past experience in dealing with regulatory queries on food, cosmetic and medical device laws

  • Good understanding of the regulation for Asia Pacific Requirements.

  • Strong knowledge on registration of food, cosmetic and/or medical device business regulations

  • Managerial: have a past managerial experience for a team > = 4 FTE minimum + experience to manage remotely a team;

  • Education:  Relevant degree in Food Science / Food Law or equivalent in related discipline

  • Pro-active: able to identify issues even before they occur, to go to the root causes and develop original solutions by thinking out of the box if needed

  • Creativity: Enjoy working for innovative companies in challenging and demanding environment and feel comfortable in evolving in multicultural teams

  • Well organized: Ability to plan multiple priorities concurrently + Organized, analytical and result-oriented individual who enjoys a fast-paced entrepreneurial environment

  • Quality focused: Detailed oriented and able to handle regulatory information and submissions with high degree of accuracy

  • Communication: Able to communicate to senior audiences well, to share knowledge and bring the best of the team

  • Language: fluent in English speaking and writing

  • Past industry experience would be a plus

Key Performance Indicators:

By end of the probation period:

  • Have conducted a diagnostic of the present organization & process: Strong points, weakness, area of improvements

  • Defined the vision for the coming month: From-To-How and build the road map and actions plan

  • Started to implement the SOP. Start by the communication flow and allocation of tasks + Defined the working process and split of responsibilities within the team (Technical / Operation / Commercial / Finance / HR)

For 2019

  • Support the development of 2019 budgeted Revenue

  • Support to development the sales pipeline à brought 2 new clients and projects in the pipeline.

  • Implementation of the SOP for internal & external Experts / especially by providing business leads in Korea, Australia and US and in Medical Devices sector;

  • 100% of compliance target on deadline for clients reports

  • Support in developing the Expert network à brought at least 3 referenced experts within the year + support in implementing & monitor an Expert Network database

  • Additional KPIs would be determine with you at the end of the probation period and according to the validated road Map

Daniel Kadunce