Quality Regulatory Associate

1. GENERAL ASSIGNMENT
Take over the responsibility of all regulatory activities for PFDC dealing with Cosmetics, biocides and Food supplements, as appropriate, of Pierre Fabre Viet Nam / Cambodia in accordance with local legislation in force.

Ensures accurate communication and coordination with the Corporate Regulatory Affairs and is supportive in all marketing regulatory activity in accordance with the Viet Nam legislation in force.

Takes part in the set-up of Master files for cosmetics developed and manufactured locally in close collaboration with Corporate Regulatory Affairs as soon as these products are internationally distributed.

Manages Regulatory survey for all types of products.

2. MAIN ASSIGNMENTS
2.1 Claims control:
 Holds local Regulatory Affairs position respecting the commitments specified in the "Power of Attorney" and written signed by [Corporate signatory], particularly regarding local inspections
 Submits locally and ensures the follow up of the Clinical Trials Applications for trials that are going to be performed in the country
 Based on the needs validated by the corporate, submits registration/notification files for Pierre Fabre products (OTC drugs, prescription Drugs, Medical Devices, cosmetics, biocides and Food supplements) to the appropriate local Authorities in accordance with the regulatory procedures and in accordance with the Viet Nam / Cambodia legislation in force
 Ensures maintenance of marketing authorisations/notifications (e.g. renewals, variations, payment of fees as relevant, …)
 Where applicable, enters regulatory files and documents in the corporate documents database OPHRYS, ARDECO (as appropriate) and regulatory data in the Corporate regulatory database.
 Prepares and validates packaging information in accordance with the Viet Nam / Cambodia legislation in force
 Validates promotional documents in accordance with the Viet Nam / Cambodia legislation in force
 Informs immediately Corporate Regulatory Affairs of submission dates and approval dates and forward immediately to Corporate Regulatory Affairs a copy of official notifications from Competent authorities with a certified translation in English or introduces it in the Corporate regulatory database.
 Informs immediately Corporate Regulatory Affairs about any question on a Pierre Fabre product raised by a local Authority or any question from a consumer association/organisation aiming at publishing study results/analysis on a product with a translation in English of requests where applicable
 Informs Corporate Regulatory Affairs of first marketing date, marketing cessation, any restriction imposed by Competent authorities to Marketing authorisations, any withdrawal of marketing authorisation, any reassessment of benefit/risk ratio imposed by Competent authorities. Completes appropriate Corporate database (e.g.: @melis) to assure complete traceability of such information.
 Organises the archiving and traceability of local files and documents.
 After prior validation by Corporate Regulatory Affairs, submits responses to request(s) for information from local Authorities.
 Sends regularly an activity report to Corporate Regulatory Affairs. On a monthly basis for Cosmetics. Frequency will be précised at Corporate level for other products.
 Assists in any regulatory activity needed to ensure the reimbursement (if applicable), customs clearance and the commercialisation according to local legislation (e.g. registration of manufacturing sites,…)
 Handling and monitoring of the labelling activities (for sub-label) in distributor by coordinating with involved departments in Pierre Fabre Vietnam and distributor to order and provide distributor sub-labels, tamper-proof seals etc.
 Handling of issues related to product quality. For other received issues, coordinate and transfer to involved departments.
2.2 Master Files (for cosmetics products)
  For all products developed and manufactured locally, prepares products Master Files in close collaboration with Corporate Regulatory Affairs according to the regulatory status of the product and its ultimate destinations (worldwide or local product).
  Upon request of Corporate Regulatory Affairs, coordinates the local collection of raw materials and finished products documentation
2.3 Regulatory survey
• Provides accurate follow-up of the local legislation for all types of products (cosmetics and Food supplements):
- organisation of survey
- impact analysis on local portfolio
- immediate reporting to the Corporate Regulatory Affairs
• Participates in the preparation of all training/awareness of Pierre Fabre employees on existing local regulations and related future changes
• Upon Corporate Regulatory Affairs request, participates in all meetings which aim at sharing international regulatory evolutions and organization/running methods within Pierre Fabre:
Participates in all possible local professional meeting with Regulatory Affairs objective.
If possible becomes member of the local association covering cosmetics products.
2.4 Managerial team and Budget
 Regularly attends meetings, call conferences, videoconferences with Corporate
 Participates in the Budget process for the Regulatory Department
 Manages on daily basis the Regulatory Department
3. CONTEXT AND ISSUES OF POSITION
 Group products Regulatory and Vigilance constraints are continuously strengthened and concern main marketing countries
 It is a basic necessity to market compliant products in order to maintain Pierre Fabre Group image towards Competent Authorities: a regular update of existing regulatory files is thus mandatory
 Diversification of products regulatory status implies new regulatory knowledge
 Acts under functional responsibility of Corporate Quality, Regulatory Affairs and Vigilancies Manager
 Appropriate organization, responsibilities sense and autonomy are required
 Works in close collaboration with Corporate Regulatory Affairs.

Degree in Pharmacy or life science .
Successful previous job experience in pharmaceutical and cosmetic industry would be preferred.
Previous experience of contacts with local authorities is required.
Behavioural skills:
- Rigour, analysis and synthesis capabilities.
- Adaptability, anticipation.
- Personal assertion.
- Open-mindedness, team spirit.
- Sense of result.
Technical and scientific skills:
- Regulations knowledge on OTC drugs, prescription Drugs, Cosmetics, Medical Devices, Food supplements, as appropriate
- Contacts with local authorities,
- Ability to understand clinical studies results (study reports) contained in regulatory files
- Ability to understand toxicological studies results and safety evaluation contained in regulatory files
- English: Fluent
- French : Would be preferred
- Knowledge on appropriate quality standards, to be able to understand results reliability and data traceability.
- Knowledge of ISO norms, ICH Guidelines, experience of inspections.

- Training course
- Health care for Staff and Dependences (PVI)
- Oversea Travelling

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