Informacje o stanowisku

Social network you want to login/join with:

Regulatory Affairs Lead, CEE Export Markets, Warsaw

Client: Haleon

Location: Warsaw, Poland

Job Category: Other

EU work permit required: Yes

Job Reference:

b016e55751ca

Job Views:

20

Posted:

23.01.2025

Expiry Date:

09.03.2025

Job Description:

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us.

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 on 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.

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

1. The evaluation of regulatory feasibility of new innovation project ideas and development and execution of robust, creative regulatory strategies.
2. The products which are placed on the market are properly authorized according to local legislation requirements in all listed countries.
3. The packaging of Haleon products complies with Haleon’s and local legislation requirements in all listed countries.
4. The advertising and promotional materials are approved (in case it is relevant) and in line with the local legislation requirements in all listed countries.
5. The activities related to import, invoicing, acquisition, distribution, and export of Haleon products are done according to local legal requirements and Haleon procedures.
6. Serving as the main contact for all communications with the competent authorities in local markets.

Regulatory responsibilities:

1. Ensure Global strategy aligned with LOC priorities in all the listed countries.
2. Ensure that all relevant authorizations, necessary to place Haleon products in all listed countries markets are obtained.
3. Ensure the development and execution of the Export Markets innovations regulatory strategies.
4. Ensure that all required new product files developed for the listed countries are submitted.
5. Perform 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.

Qualifications & Skills:

1. University degree B.Sc., M.Sc. or equivalent in Life science/Pharmaceutical related science (e.g. Chemistry, Pharmacy, Biology, Biochemistry)
2. 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
3. Proven experience in Regulatory Affairs with knowledge of lifecycle requirements for regulated products
4. Strong leadership skills
5. Planning and organization skills
6. Strategic thinking

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

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives. We believe in an agile working culture for all our roles.

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.

Warszawa - Oferty pracy w okolicznych lokalizacjach