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Regulatory Affairs Manager for CEE Export Regions

2 months ago

Citrus Heights, California, United States Haleon Full time

Welcome to Haleon, a pioneering consumer health organization dedicated to enhancing everyday health for millions globally. Our portfolio features iconic brands such as Sensodyne, Panadol, and Voltaren, all rooted in trusted science and deep human insights. We are committed to fostering an environment where innovation thrives and where our culture is shaped by our collective contributions.

This is a pivotal moment to become part of our journey and influence the future of health.


Role Overview

This position is integrated within the Local Operating Company/Export Markets to ensure compliance with regulatory mandates across designated countries for commercial operations. The role is essential for managing systems and activities that significantly impact 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, as well as CIS countries. By leading the regulatory team for CEE Export Markets, you will have the opportunity to design processes that meet stringent regulatory standards while emphasizing innovation. This role is part of the global R&D Regulatory Affairs EMEA-LATAM structure, 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 manage related activities; Ensure the proper maintenance of existing licenses; Guide direct reports to meet Haleon expectations and develop appropriate growth plans;

As a Regulatory Affairs Lead for CEE Export Markets , your responsibilities will include:

Evaluating the regulatory feasibility of new innovation projects and developing effective regulatory strategies to facilitate new initiatives in the Export Markets; Ensuring that products launched in the market are authorized according to local legislation in all designated countries; Confirming that the packaging of Haleon products adheres to both Haleon and local legislative requirements; Approving advertising and promotional materials in compliance with local laws; Ensuring that all activities related to the import, invoicing, acquisition, distribution, and export of Haleon products comply with local legal requirements and Haleon procedures; Acting as the primary liaison for communications with local regulatory authorities in all listed countries; Gaining a comprehensive understanding of various business models in the region and providing support as needed;

Regulatory Responsibilities:

Product Registration:

Ensure alignment of global strategy with local priorities across all listed countries. Obtain all necessary authorizations to market Haleon products in the designated countries. Develop and implement regulatory strategies for innovations in the Export Markets. Submit all required new product files for the listed countries. Maintain product licenses in compliance with legal requirements across all listed countries. Establish a robust regulatory process to support Haleon's launch plans. Ensure product labeling meets Haleon and local legislative standards. Keep all regulatory databases accurate and up-to-date. Build relationships with relevant regulatory authorities to enhance product approval rates and reduce approval timelines.

Artwork Management:

Ensure that labeling text and packaging components comply with registered details and corporate prescribing information.

Communications:

Review and approve promotional and advertising materials, ensuring compliance with Haleon and local legal standards. Ensure timely approval of promotional materials by relevant authorities, responding to comments and providing necessary evidence to support claims.

QMS Responsibility:

Ensure full regulatory compliance. Conduct L1 audit plans in all relevant countries. Perform L1 audits.

Qualifications & Skills:

A university degree (B.Sc., M.Sc., or equivalent) in Life Sciences or Pharmaceutical-related fields (e.g., Chemistry, Pharmacy, Biology, Biochemistry). A minimum of 5 years of leadership experience in Regulatory Affairs, with knowledge of EU, non-EU, and CIS environments for medicines, and ideally for medical devices, cosmetics, and food supplements. Proven expertise in Regulatory Affairs with an understanding of lifecycle requirements for regulated products. Familiarity with different business models, such as distributor models. Knowledge of regulatory strategies for submission filings. Strong leadership, planning, organization, and strategic thinking skills. Ability to understand cultural differences and experience working within diverse regulatory environments.

At Haleon, we are committed to continuous progress and improvement in everyday health. We offer a comprehensive benefits package tailored to the location of the role.

Location – this role is based in: Poland, Warsaw or Hungary, Budapest

We celebrate diversity and promote an inclusive environment where every individual can thrive. We encourage a flexible working culture and welcome discussions about how we can accommodate your needs.

Haleon is an Equal Opportunity Employer, ensuring that all qualified applicants 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, or any other protected status.