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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 wellness for millions globally. Our strength lies in our diverse portfolio of trusted brands, including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum, which we advance through a blend of profound human insight and scientific expertise. We foster a collaborative environment where every team member contributes to shaping our unique culture.
This is an exceptional opportunity to be part of a transformative journey. We invite you to help us define the future of health.
Position Overview
The role is integrated within the Local Operating Company/Export Markets to ensure compliance with regulatory mandates across designated countries for commercial operations. This position is vital for the effective management of systems and activities that significantly influence regulatory adherence 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, along with CIS countries. By leading the regulatory team for CEE Export Markets, you will have the opportunity to design and implement processes that uphold high regulatory standards while emphasizing innovation. This role is part of the global R&D Regulatory Affairs EMEA-LATAM framework, reporting directly to the R&D BU CEE Lead.
Key Responsibilities:
Align the Regulatory Strategy with local business objectives and global regulatory frameworks; Oversee the registration of products intended for the aforementioned markets by Haleon and related activities; Ensure the proper maintenance of existing licenses; Guide direct reports to meet Haleon’s expectations and develop their professional growth plans;As a Regulatory Affairs Lead for CEE Export Markets , your responsibilities will include:
Evaluating the regulatory feasibility of new innovation project concepts and developing robust regulatory strategies to facilitate new simple innovation projects for the Export Markets; Ensuring that products marketed are authorized in accordance with local legislation across all listed countries; Verifying that Haleon product packaging complies with both Haleon’s and local legislative requirements in all listed countries; Approving advertising and promotional materials, ensuring compliance with local legislation in all listed countries; Ensuring that activities related to the import, invoicing, acquisition, distribution, and export of Haleon products adhere to local legal requirements and Haleon procedures; Acting as the primary contact for all communications, ensuring similar representatives are appointed in all listed countries with the relevant authorities; Gaining a comprehensive understanding of various business models in the region and providing support aligned with local needs;Regulatory Responsibilities:
Product Registration:
Ensure global strategies are aligned with local priorities in all listed countries. Obtain all necessary authorizations to market Haleon products in all listed countries. Develop and execute regulatory strategies for innovations in the Export Markets; Submit all required new product files for the listed countries; Perform all necessary tasks to maintain product licenses in compliance with legal requirements in all listed countries; Implement an effective regulatory process that enables Haleon to meet launch timelines; Ensure product labeling aligns with Haleon and local legislative requirements; Maintain accurate and updated regulatory databases; Build relationships with relevant regulatory authorities to maximize product approvals and minimize approval timelines, in accordance with local laws.Artwork Management:
Ensure labeling text and packaging components comply with local registered details and corporate prescribing information.Communications:
Review and approve promotional and advertising materials, ensuring compliance with Haleon and local legal standards. Ensure promotional and advertising materials receive timely approval from relevant authorities, responding to comments and providing supporting evidence as necessary.Quality Management System Responsibility:
Ensure full regulatory compliance. Ensure L1 audit plans are executed in all relevant countries. Conduct L1 audits.Qualifications & Skills :
University degree (B.Sc., M.Sc. or equivalent) in Life Sciences or Pharmaceutical-related fields (e.g., Chemistry, Pharmacy, Biology, Biochemistry) Minimum of 5 years of leadership experience in Regulatory Affairs, with a solid understanding of the EU, non-EU, and CIS environments for medicines, and preferably for medical devices, cosmetics, and food supplements as well; Proven expertise in Regulatory Affairs with knowledge of lifecycle requirements for regulated products; Understanding of the varying needs across different business models, such as distributor models; Knowledge of regulatory strategies for submission filings; Strong leadership capabilities; Excellent planning and organizational skills; Strategic thinking abilities; Experience working with diverse regulatory environments and understanding cultural differences;At Haleon, we believe in continuous growth and improvement. We strive to create a workplace where everyone feels valued and can thrive.
Enhancing everyday health requires commitment, energy, and effort.
We offer a comprehensive benefits package tailored to your location.
Location – this role is based in: Poland, Warsaw or Hungary, Budapest
Please keep a copy of this job description for your reference.
#Li-Hybrid
At Haleon, we celebrate our diverse workforce by fostering an inclusive environment that values unique perspectives, encourages curiosity, and promotes equitable outcomes for all. We are committed to creating a climate where diversity is celebrated, respect is paramount, and every individual can thrive. We advocate for an agile working culture across all roles. If flexibility is important to you, we encourage you to discuss potential opportunities with our hiring team.
As part of the application process, we will request some personal information, which is voluntary. This information will help us consider a diverse pool of qualified candidates and assess our progress towards inclusion and diversity goals. We appreciate your cooperation. Please rest assured that hiring managers will not have access to this information, and we will treat it confidentially.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.
Please note that if you are a US Licensed Healthcare Professional or a Healthcare Professional as defined by the laws of your state, Haleon may be required to capture and report expenses incurred on your behalf during the interview process. This is necessary to ensure compliance with federal and state US Transparency requirements.
