Regulatory Affairs Manager

  • Full-time
  • Activity: Animal Nutrition & Health
  • Contract type: Fix term contract

Company Description

As a global key player in yeasts and fermentation, Lesaffre designs, manufactures and markets innovative solutions for Baking, Food taste & pleasure, Health care and Biotechnology.
Family group born in northern France in 1853, now a multi-national and a multicultural company, Lesaffre is committed to working with confidence to better nourish and protect the planet.
In close collaboration with its clients and partners, Lesaffre employs 11 000 people in more than 50 countries.
Lesaffre achieves a turnover of 3 billion euros.

Job Description

-  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 master’s 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

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