Regulatory Affairs Manager

-  Ensure a regulatory watch and identify regulatory requirements in China as regards feed products

 To do this use all the information available at the group level (related to the GRAD) or by using the local resources

 Verifies that no change in the official Chinese texts is likely to interfere with the free marketing of products sold locally by Phileo and the exportation of products manufactured in China

 Ensures that all regulatory requirements and constraints are considered in the construction of registration dossiers and the labelling of Phileo products in China.

 Ensure that all imported products could be compliant with regulations before and after importation.

- Prepare and draft approval dossiers of Phileo products according to deadlines and product launch schedules

 Consolidate the required data at the establishment of the Chinese dossiers:

 Administrative (legalized documents free sale certificates manufacturing licences quality certification documents letters of authorization)

 Scientific (analytical trial reports toxicological and safety data).

 In link with Phileo Downstream Development and Regulatory Affairs R&D or Corporate entities local plants or consultants coordinate missing studies in the field of Identity Efficacy or Safety of products.

 Collect the Chinese documents required for the market access of products manufactured in China.

 Ensure follow-up and renewal of authorizations and labelling of Phileo products

 Ensures anticipation and respect for deadlines and completeness of Chinese registration working closely with the local authorities as well as local resources

 verifies that labelling fits well within the rules set by the Chinese authorities.

-  Communicate to the marketing and sales teams the progress of the Phileo products registration dossiers to contribute to the success of new product launches

 Attend regular reporting meetings with sales managers to better define regulatory needs with them

 Support the customer service and sales teams by giving them the relevant regulatory information (advice samples shipment customs issues)

-  In link with Greater China regulatory team and Phileo Regulatory Affairs Cluster and Group Regulatory Affairs Department (GRAD) conduct lobbying actions and participate in meetings of local professional organizations with supervision and delegation by the manager

 Works in close relationship with the local Regulatory team Phileo team and GRAD to undertake lobbying actions within these various associations

 Insure a complete reporting in follow-up of the meetings of these different associations.

 Develop a local network dedicated to regulatory affairs

 Develop close links with the Phileo Regulatory Affairs Corporate (GRAD) and local entities (Plants) to optimise the exchanges especially in terms of regulatory documents

 Identify and select the best relevant consultants able to help the global and local businesses.

 Finish other regulatory affairs tasks arranged by the manager.

Qualifications :

- DVM or minimum masters degree in animal/feed/veterinary science or bioscience/relevant science field with at least five years experience in a regulatory affairs position in relevant industry.

-  Strong expertise in Regulatory Affairs (especially Chinese Feed and Feed Additives Dossiers)

- Project management

- A good oral and written English is essential

- Global Company Player spirit

- High relationship and leadership capabilities

- Good team working abilities and adaptability

- Good communication skills

- Sense of achievement

Remote Work :

No

Employment Type :

Full-time