Regulatory Affairs Lead, CEE Export Markets

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people.

By growing and innovating our global portfolio of category-leading brands including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum through a unique combination of deep human understanding and trusted science.

What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours.

Care to join us. It isn’t a question.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

Role overview

The job is embedded in the Local Operating Company / Export Markets to ensure that the mandated Regulatory requirements in the assigned countries, for commercial operating units are met.

The role is critical to the effective

management of systems and activities that are crucial or have a direct impact to the regulatory compliance, as well as the business.

Export Markets is a complex region of 25 countries including small EU member states and non-EU countries of the Central and Eastern European region as well as the CIS countries.

By leading the CEE Export Markets regulatory team, both direct and indirect reports, this is a great possibility to test and learn how to design processes applicable across all markets to meet high regulatory standards, including strong focus on innovation aspects.

The role is positioned within global R&D Regulatory Affairs EMEA-LATAM structure and as a Regulatory Lead for CEE Export Markets, you will report directly to R&D BU CEE Lead.

Key Roles & Responsibilities :

• Ensure the Regulatory Strategy is in line with Local business priorities and Global Reg. strategies;
• Ensure the registration of products intended to be placed on the above listed markets by Haleon and related activities;
• Ensure the appropriate maintenance of the existing licenses;
• Ensure the direct reports meet Haleon expectation and have appropriate development plans;

As a Regulatory Affairs Lead, CEE Export Markets you will be responsible for ensuring :

• The evaluation of regulatory feasibility of new innovation project ideas and development and execution of robust, creative regulatory strategies to enable new simple innovation projects for the Export Markets;
• The products which are placed on the market are properly authorized according to local legislation requirements in all listed countries;
• The packaging of Haleon products complies with Haleon’s and local legislation requirements in all listed countries;
• The advertising and promotional materials are approved (in case it is relevant) and in line with the local legislation requirements in all listed countries;
• The activities related to import (of non-medicinal products), invoicing, acquisition, distribution and export of Haleon products are done according with the local legal requirements and Haleon procedures;
• Serving as the main contact for all communications and making sure similar person appointed in all listed countries with the competent authorities in local markets;
• Fully understanding different business models in the area and supporting in line with local need;

Regulatory responsibilities :

Product registration :

Ensure Global strategy aligned with LOC priorities in all the listed countries.

• Ensure that all relevant authorizations, necessary to place Haleon products in all listed countries markets are obtained;
• Ensure the development and execution of the Export Markets innovations regulatory strategies;
• Ensure that all required new product files developed for the listed countries are submitted;
• Performs all specific tasks required in order to keep product licenses up-to-date, valid and in compliance with the legal requirements in all the listed countries;
• Implements a highly effective regulatory process that enables Haleon to meet the launch plans;
• Ensure the products labeling is in line with Haleon and local legislation requirements;
• Ensure all regulatory databases are accurate and updated;

Build contacts with relevant regulatory authorities to maximize the number of product approvals and minimize the approval timing, according to country laws.

Artwork management :

Ensure the labelling text and packaging components are in compliance with local registered details and corporate prescribing information.

Communications :

Check and approve promotional and advertising materials, ensuring that materials comply with Haleon and local legal requirements.

Ensure the promotional and advertising materials are approved (by relevant authorities in case it is required) before dissemination in a timely manner.

Respond to authorities comments, offer supporting evidence and argumentation for our claims, in order to obtain timely approval in case it is required.

QMS Responsibility :

Ensure full Regulatory Compliance.

Make sure L1 audit plans are done in all countries where relevant.

Carry on L1 audits.

Qualifications & Skills :

University degree B.Sc., M.Sc. or equivalent in Life science / Pharmaceutical related science (e.g. Chemistry, Pharmacy, Biology, Biochemistry)

Minimum 5 years leadership experience in Regulatory Affairs, understanding EU-non EU, CIS environment for medicines and as an advantage also for medical devices, cosmetics and food supplements

Proven experience in Regulatory Affairs with knowledge of lifecycle requirements for regulated products

Understanding the different needs in different business models e.g. distributor model

Knowledge in regulatory strategy for filing of submissions

Strong leadership skills

Planning and organization skills

Strategic thinking

Understand cultural difference-experience working with different external Regulatory environment

None of us should ever feel like we are standing still. Instead, we want Haleon to be a place where we feel like we are always progressing.

Improving everyday health takes dedication. Energy. Effort.

So we look to reward your contribution with a benefits package depending on a location.

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

Please save a copy of the job description, as this may be helpful to refer to once the advert closes.

Li-Hybrid

Care to join us. Find out what life at Haleon is really like www.haleon.com / careers /

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