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Regulatory Affairs Associate- Iberia

Regulatory Affairs Associate- Iberia

Reckitt Benckiser LLC, Cantabria, Spain, Cantabria, España
Hace 10 días
Descripción del trabajo

As Regulatory Affairs Associate, you will manage projects from day one, making decisions with real impact and driving performance through brands with purpose to create a cleaner & healthier world. This is your chance to provide regulatory support for new products and ensure ongoing compliance, leading to the growth of our Spanish business.

Your responsibilities

  • Ensure the registration and regulatory compliance of Reckitt Benckiser’s marketed products with relevant Spanish and European regulatory requirements to bring competitive advantage to our brands.
  • Documentation Management System : Ensuring the compilation of national dossiers for submissions to authorities working closely with company personnel (e.g., R&D SSG, Category R&D, Global RSE, etc.) and contractors, as required. Ensuring the preparation, maintenance, and update of product registration / license and regulatory compliance files. Ensuring the amendment of registration dossiers as necessary for country-specific regulatory requirements and overseeing the submission of registration / variation / notification applications. Managing and maintaining regulatory documentation filing system.
  • Coordinating of Free Sales Certificates. Developing national texts (e.g., PIL, SPC, packaging) including coordination of translations.
  • Regulatory Requirements : Monitoring and interpreting local regulatory issues and trends that will impact the marketability of company products, ensuring that the company is aware of significant local regulatory issues, and proactively leading the development and implementation of strategies to ensure regulatory compliance efforts that result in competitive advantage.
  • Regulatory and Safety Advice : Providing regulatory and product compliance expertise in the area of advertising, label claims, and printed materials for existing and new products. Protecting key brand and product claims using medical and regulatory expertise. Providing technical support and advice to respond to consumer and legal inquiries, regulatory issues for our products marketed in Spain.
  • Specific Local Requirements : Ensure that Reckitt Benckiser complies with all requirements set by Spanish authorities.
  • External Affairs : Interfacing with local government agencies and industry associations to assess the impact and implementation of required company compliance with all regulations, laws, and industry policies that affect the ingredients, packaging, marketing, advertising, labeling, and production of our products. Representing company interests with local government agencies, industry associations, and / or other organizations for the purpose of negotiating legislation, regulations, and / or guidelines that do not impose excessive or unfair burdens on our industry or products.
  • Quality Management System : Help managing and maintaining relevant Standard Operating Procedures as part of the QMS. Help with GDP compliance including customs documentation, batch release, or any other activity related to GDP compliance of our portfolio.

The experience we're looking for

  • Science-related degree : Pharmaceutics, chemistry, human biology, human medicine, veterinary medicine, biochemistry, or biology.
  • Knowledge of Spanish and European regulatory legislation.
  • Demonstrated ability to handle competing priorities effectively.
  • Proven track record in active collaboration with R&D and non-R&D functions as well as third parties.
  • Ability to work in multi-functional and multi-cultural project teams.
  • Clear and logical thinker with the ability to recognize patterns and develop innovative solutions.
  • Ability to apply argumentation in order to influence at all levels externally and internally.
  • Proactive self-direction with a high level of initiative and persistence and a very hands-on approach to results delivery.
  • The ability to effectively manage projects and relationships with local partners, contractors, and consultants to achieve Reckitt Benckiser’s objectives.

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