As the Regulatory Affairs Specialist, you will play a critical role in enabling the PHC business for the relevant portfolio within and outside Europe. You will coordinate Regulatory Life Cycle Management activities across multiple countries, ensuring compliance with regulatory requirements and maintaining Global Master Dossiers. Additionally, you will provide strategic input into Regional Product labeling and approval to facilitate commercial activation of product launches.
Your key responsibilities will be:
* To build medicinal capability within Regulatory Affairs Life Cycle Management and ensure medicinal aspects are integrated into projects, work processes, and systems.
* To coordinate changes to existing products/dossiers to maintain market presence and compliance.
* To act as the primary point of contact for local regulatory colleagues, fostering effective communication and collaboration.
* To maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance.
* To advise the organization on potential regulatory risks and recommend compliant actions.
* To ensure regulatory assessments are conducted for change controls in the Veeva Quality Tracking system.
* To maintain and update the Veeva Regulatory Information Management system for all activities under role responsibility.
* To contribute to new regulatory policies, systems, and processes to reinforce governance and compliance across LCM and the Regulatory Affairs function.
Requirements:
Education: Minimum of a Master's degree in pharmacy, engineering, or chemistry with knowledge in Regulatory Affairs.
Languages: Proficiency in English.
Professional experience: 1-2 years of initial regulatory affairs experience, preferably in consumer health, and across multiple regulatory classification areas.
Motivation: Strong motivation for dossier maintenance and product change management.
Skills: Proficiency in working with complex Regulatory databases; ability to work independently in a matrix environment to build superior relationships with stakeholders.
Initiative: Strong initiative and follow-through with accountability for work quality.
Organizational skills: Ability to handle a complex product-country portfolio with a solution-oriented attitude.
Communication: Excellent attention to detail, good communication, and presentation skills.
Results-oriented: Ability to influence others and drive results.
Adaptability: Openness to change and ability to think outside the box.
If you are a motivated and results-oriented individual with a passion for Regulatory Affairs and a desire to make a difference in the pharmaceutical industry, we encourage you to apply for this exciting opportunity.
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