CEE Regulatory Innovation Manager

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, 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.

About the role

As the CEE Regulatory Innovation Manager you will lead regulatory strategy and will drive innovation to help drive growth opportunities for diverse categories and portfolio of Haleon’s products, while ensure to maintain the core for the Central and Eastern Europe (CEE) Business Unit (BU).The role will be responsible for developing appropriate regulatory strategies, and identifying risks, risk mitigation and probability of success, to enable informed decision-making by the BU R&D and BU Leadership.

You will get an opportunity to develop and execute robust, creative regulatory strategies to enable new innovation projects for the BU, contributing to the development of global and / or area / local Regulatory strategies as well as to ensure compliance and translate area / global strategies into executable plans for area / LOCs.

In this role you will build a network of collaborative relationships within the Business Unit, working closely with the R&D Innovation Lead, the Commercial innovation and Brand Managers, Medical, LOC Regulatory, Project Managers and Supply Chain colleagues. The role will interface with Global functions, such as Global Safety & Medical, Formulation and Development, QSC, CMC and Regulatory Operations to ensure delivery of dossier development to support agreed innovation, timely submissions and approvals.

The role can be based in one of the CEE locations such as Poland / Warsaw, Czech Republic / Prague, Romania / Bucharest, Hungary / Budapest or Athens / Greece.

Role Responsibilities

Being responsible for regulatory feasibility assessments for new product ideas across the portfolio within the CEE Business Unit, including recommendation of regulatory probability of success and risk mitigation to enable technical risk assessment and informed decision-making by BU Leadership.

Development, alignment and execution of creative regulatory strategies to deliver BU-led innovation projects, optimizing claims and speed to market

Evaluation of regulatory feasibility and assessment of in-licensing opportunities for the Business Unit in connection with BU-led innovation

Leading and overseeing development of high-quality dossiers, technical documentation, Product Information Files, and labelling for submissions associated with BU-led innovation, in close cooperation with local regulatory and medical, CMC, GSM, R&D.

Coordination of DCP or MRP registration procedures for medicines across markets, leading internal rapid response teams, and ensuring optimal Regulatory Agency interactions and approval timings.

Providing clear guidance to the project team on regulatory deliverables, resource needs, key milestones and timings.

Supports the identification and escalation of regulatory risks and challenges or roadblocks as needed.

Building relationships with all relevant internal stakeholders, in the BU, Region and Global functions.

Ensuring optimal interactions with external stakeholders, including regulatory agencies, professional organisations and consultants as needed.

Coordinating major maintenance activities

Basic Qualifications :

Minimum BSc Degree in Pharmaceutical or Life Science area (e.g. Pharmacy, Bio-Sciences / Biology, Chemistry)

Minimum 5 years’ experience within Consumer Healthcare, Pharmaceutical industry across OTC, Rx, health supplements products, preferably with at least 2 years working on innovation in consumer healthcare industry with solid results.

Proven ability to act as a strategic business partner with demonstrated commercial awareness.

Solid experience and skills in regulatory project management.

Experience managing national and / or regional registration / notification processes, with strong knowledge and direct experience of regulatory requirements across multiple markets in CEE (medicines, medical devices, and food supplements).

Knowledge of regional dossier requirements, experience of reviewing clinical and non-clinical data and preparing global or regional dossiers for submission

EU Regulatory Procedures : Proven experience in handling EU regulatory procedures (CP, DCP, MRP).

Demonstrated previous experience of communicating with external regulatory agencies and capability in leading the preparation of cross-functional and cross-country responses to HA questions.

Fluent in English - Excellent written and verbal communication skills.

Proven ability to communicate complex information to a variety of audiences in both verbal and written format.

Creative and strategic thinking, can-do attitude, analytical and problem-solving skills.

Demonstrated experience of internal and external stakeholders management.

Strong collaboration and interpersonal skills, with ability to work effectively across organisations and levels.

Location – this role is based in one of the following locations :

The role can be based in one of the CEE locations such as Poland / Warsaw, Czech Republic / Prague, Romania / Bucharest, Hungary / Budapest or Athens / Greece.

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

What we offer?

Haleon rewards your contribution with a benefits package depending on each CEE locations. More detailed information will be disclosed at a further stage of recruitment process.

Haleon offers a dynamic hybrid work model, allowing you to achieve a balance between professional and personal life. Enjoy an attractive reward package that includes an annual bonus, awards for outstanding performance, and recognition for additional achievements and engagement. We prioritize your well-being by providing extensive support for work-life balance, offering flexible working solutions, including the possibility of very flexible hybrid work and engaging in various health and well-being activities. Our commitment to diversity is reflected in our open and inclusive environment, which welcomes individuals of all backgrounds, embracing diversity in gender, race, ethnicity, sexuality, disability, and any other characteristic. As part of our commitment to your health, we provide a private medical package for both employees and their eligible counterparts as per local policy. Our personalized learning approach ensures continuous growth and development in your professional journey. Join a supportive community that values collaboration and inclusivity and take part in integration events that foster a sense of belonging.

Li-hybrid

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

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information 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.

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