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    Regulatory Affairs Manager - Barcelona, España - Robert Walters

    Robert Walters
    Robert Walters Barcelona, España

    hace 5 días

    Robert Walters background
    De jornada completa Farmacéutica / Biotecnología
    Descripción

    Robert Walters is hiring a Regulatory Affairs Manager in Barcelona.

    Our client is an important pharmaceutical company specialized in medical nutrition.

    As a Regulatory Affairs Manager, the candidate reports to the Director of RD&A.
    Its objective is to ensure regulatory compliance of the product portfolio (marketed and investigational products) in all the territories where the company operates, as well as to design and implement the registration strategy for new products in line with the R&D and global business strategy.
    The position necessarily involves collaborating with the different company departments responsible for the design, manufacturing and marketing of new products and before the corresponding health and food authorities such as AESAN, EFSA, FDA, cFDA among others. It also requires collaborating with Regulatory Affairs departments from the commercial partners of the company to facilitate a fast and successful submission of the regulatory documentation of company's products when agreed and needed.
    The regulatory Affairs Manager will create the external network of specialists to support a fast and consistent extension of the approvals of the products across the geographies prioritized in the strategy and business plans.


    • Ensure regulatory compliance in all markets.

    • Submissions of new applications, variations, renewals and procedures national and worldwide.

    • Design the regulatory strategy in accordance with the business objectives and regulatory options.

    • Register new products in each territory according to strategy ensuring the quality, content and format of regulatory submissions.

    • Customize product registrations according to the requirements of each country.

    • Representation of the company before the food and health authorities and institutions of each country or region. Represent the company in interactions with reviewers to pursue approvals, obtain information and clarify issues.

    • Review and approval of packaging & labelling. Participate in the circuit of approval of promotional material and website content.

    If you are interested in this vacancy and you have experience in the rol, you can send me your cv to

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