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Regulatory Affairs Manager for CEE Export Regions
2 months ago
Welcome to Haleon, a pioneering consumer health organization dedicated to enhancing everyday health for millions globally. Our success is driven by our innovative approach and our commitment to trusted science, represented by our renowned brands such as Sensodyne, Panadol, and Voltaren.
We are at a pivotal moment in our journey, and we invite you to be part of our transformative vision.
Role Overview
This position is integrated within the Local Operating Company/Export Markets, focusing on fulfilling the regulatory obligations across the designated countries for our commercial operations. The role is essential for managing systems and activities that directly influence regulatory compliance and business operations.
The Export Markets encompass a diverse region of 25 countries, including both small EU member states and non-EU nations in Central and Eastern Europe, as well as CIS countries. Leading the regulatory team for CEE Export Markets, you will have the opportunity to design processes that adhere to high regulatory standards while emphasizing innovation.
Key Responsibilities:
- Align the Regulatory Strategy with local business objectives and global regulatory frameworks;
- Oversee the registration of products intended for the markets listed above and manage related activities;
- Ensure the proper maintenance of existing licenses;
- Guide direct reports to meet Haleon’s expectations and establish development plans;
As the Regulatory Affairs Lead for CEE Export Markets , your responsibilities will include:
- Evaluating the regulatory feasibility of new innovation projects and developing effective regulatory strategies for new initiatives;
- Ensuring that products launched in the market are authorized according to local legislation in all designated countries;
- Verifying that product packaging complies with Haleon’s and local regulations;
- Approving advertising and promotional materials to ensure compliance with local laws;
- Managing activities related to the import, invoicing, acquisition, distribution, and export of Haleon products in accordance with local legal requirements;
- Acting as the primary contact for communications with local regulatory authorities;
- Understanding various business models in the region and providing support as needed;
Regulatory Responsibilities:
Product Registration:
- Ensure alignment of global strategy with local priorities in all listed countries;
- Obtain all necessary authorizations for placing Haleon products in the markets;
- Develop and implement regulatory strategies for innovations in Export Markets;
- Submit all required new product files for the listed countries;
- Maintain product licenses in compliance with legal requirements;
- Implement an efficient regulatory process to support product launch timelines;
- Ensure product labeling meets Haleon and local legislation;
- Keep regulatory databases accurate and up-to-date;
- Build relationships with regulatory authorities to enhance product approval rates.
Artwork Management:
- Ensure labeling and packaging components comply with registered details and corporate information.
Communications:
- Review and approve promotional materials, ensuring compliance with Haleon and local regulations;
- Ensure timely approval of promotional materials by relevant authorities when necessary.
Quality Management System Responsibility:
- Ensure full regulatory compliance;
- Conduct L1 audits in relevant countries.
Qualifications & Skills:
- University degree (B.Sc., M.Sc. or equivalent) in Life Sciences or Pharmaceutical-related fields;
- Minimum of 5 years of leadership experience in Regulatory Affairs, with knowledge of EU, non-EU, and CIS regulations for medicines, and preferably for medical devices, cosmetics, and food supplements;
- Proven expertise in regulatory affairs with an understanding of lifecycle requirements for regulated products;
- Strong leadership, planning, organization, and strategic thinking skills;
- Experience working with diverse regulatory environments.
At Haleon, we believe in continuous progress and a culture that values dedication and effort. We offer a comprehensive benefits package tailored to your location.
Location: This role is based in Poland or Hungary.
Haleon is committed to fostering an inclusive environment that values diverse perspectives and promotes equitable outcomes for all.
