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  • News & Media
  • CDI

    Regulatory affairs Manager (M/F)

    The candidate will carry out the following tasks:

    • Type of contract : CDI
    • Localisation : Paris, Gare de Lyon
    • Availability : ASAP
    • Remuneration : Based on the profile

    Your mission

    Definition and implementation of a regulatory strategy to place products on the market
    • Speaking with research teams, the marketing and quality department, in order to grasp the features of the product developed;
    • Supervision of the putting together and monitoring of files of authorisation of placing on the market and/or of certification (MA/CE marking)
    • Advice and assistance for the product communication (marketing, notice, labelling, scientific communication…)
    • Identification and analysis of regulatory difficulties and risks before and/or after the product is placed on the market
    • Defining a regulatory strategy based on the company’s commercial and R&D policy;
    • Integrating the financial aspect in the management of regulatory affairs in order to contribute to the optimisation of their cost.

    Drafting and monitoring of regulatory files
    • Ensuring access of the product to the market by carrying out the necessary regulatory steps: obtainment, amendment and maintaining of authorisation to place on the market;
    • Collecting tests and trials and production, and the various technical documentations from the R&D departments in order to put together the regulatory files;
    • Facilitating the preparation meetings of all registration files;
    • Drafting the registration and authorisation files of placing on the market and submitting them to the regulatory authorities;
    • Monitoring the approval files and the registration processes with the ministries;

    Facilitation of the relationship with the regulatory authorities / lobbying
    • Answering the requests expressed by the regulatory authorities: technical documents, additional information regarding the proper use of the product;
    • Ensuring the transparency of the marketing of the company’s products;
    • Ensuring the renewal of authorisations of placing on the market throughout the product’s lifecycle;
    • Participating in professional associations and relevant inter-branch organisations in France and in Europe and defending ?nsect’s interests there, in accordance with its vision and values;
    • Communicating on the industry and ?nsect’s work in this regard at conferences, conventions, etc.

    Support to product development
    • Contributing to the definition and drafting of the product’s requirements specification in order to ensure that regulatory constraints are duly complied with;
    • Providing support to the product launch regarding legal and regulatory aspects;
    • Anticipating changes in regulations in order to introduce the necessary changes regarding the new requirements in the development process;
    • Ensuring an active regulatory and legislative watch in the scope of activity of the company in order to offer adaptation scenarios and new approaches;
    • Monitoring the proper compliance with the regulations pertaining to advertisement, packaging, advertising materials and documents

    Required Skills

    • At least 8 years of experience;
    • Excellent legal knowledge in order to have the company comply with applicable regulatory constraints
    • Excellent knowledge of the agricultural and agri-food industries and of the French and European regulatory contexts in these industries
    • Strong ability to understand the technicality of products in view of duly obtaining the approvals/authorisations
    • Thoroughness to ensure strict compliance with applicable quality standards;
    • Synthesis and analysis skills in order to discern, among the possible avenues, the relevant registration procedures that meet the company’s needs;
    • Ability to anticipate in order to optimise the product development process based on future regulatory changes;
    • Organisational ability in order to enforce the applicable regulatory constraints;
    • Writing skills to draft the regulatory reports necessary for the proper placing on the market;
    • Excellent interpersonal and communication skills, in order to ensure the interface with regulatory authorities and to represent the company in professional associations, conferences, etc;
    • Ability to work as a team since this role falls within the scope of the company’s overall projects;
    • Strong ability to adapt in order to collaborate with all departments of the company;
    • Command of the English language, both oral and written.

    There is no ideal candidate. Please do not hesitate to apply if you do not have all the prerequisites but are sufficiently motivated to join us.