Regulatory Affairs & Safety Associate

Regulatory Affairs & Safety Associate

Reckitt

Prague, Czech Republic

About the role

Reckitt is seeking a dedicated Regulatory Associate, a role that sits at the core of our innovation process, ensuring that our new product developments meet global regulatory requirements with precision. You will act as a catalyst for change, using your detailed knowledge to create comprehensive dossiers crucial for product registrations. At Reckitt, every individual's contribution is key, and your role will be pivotal in navigating the intricate regulatory landscape to deliver products that enrich lives every day.

Your responsibilities

• Deliver all activities related to the implementation of regulatory and product safety strategies for Reckitt Core products within the CZ and SK business.
• Works independently at RB Regulatory Excellence Project as required by Reckitt (project oriented to improving quality of dossier submitted to Regulatory bodies related to regulated Health and Personal Care RB products).
• Responsibility for preparation and coordination of regulatory submissions and strategies.
• Actively cooperates with Regulatory Affairs & Safety Manager CZ/SK regarding projects as per agreed timelines.
• Work collaboratively with the Regulatory Affairs & Safety Manager CZ/SK to maintain and improve current product portfolio of regulated Health and Personal Care RB products.
• Cooperate on the resolution of regulatory issues affecting the relevant products and provide advice to Regulatory Affairs & Safety Manager CZ/SK on registration and regulatory compliance issues.
• Provide regulatory affairs support and consultancy to internal stakeholders within the CZ and SK business in a professional way.
• Provide regulatory support to quality functions to ensure Core Products are maintained in compliance with local requirements.
• Work closely with external partners, authorities, inspections, local trade associations, distributors, contractors to ensure that regulatory affairs issues are properly managed and resolved.
• Approval of artworks and promotional materials from regulatory point of view.
• Keep record of the documents, maintain regulatory database.
• Assist the Regulatory Affairs & Safety Manager CZ/SK and Regulatory Director Poland & EE and Global and Local Functions to implement Company regulatory, safety & environmental policies, guidelines and procedures.
• Other tasks assigned by manager.

The experience we're looking for

• Educated to honors degree level in Pharmacy, Chemistry, Biological Science or equivalent degree.
• Ability to understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders.
• Fluent in English.
• Minimum 2 years experience working within a Regulatory Affairs environment either in pharmaceutical company, FMCG Company (local or international) or Governmental or laboratory environment.
• Basic Excel.