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Cee Regulatory Innovation Manager - Warsaw, Polska - Haleon
Opis
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.
In an environment that we're co-creating.
And a culture that's uniquely ours.
Care to join us.
It isn't a question.
This is an exciting time to join us and help shape the future.
It's an opportunity to be part of something special.
Regulatory Innovation Manager As the Regulatory Innovation Manager , you will lead regulatory strategy and drive simple innovation to help drive growth opportunities while ensure to maintain the core for the Central and Eastern Europe (CEE) Business Unit (BU).
You will contribute to global and local regulatory strategies, ensuring compliance and translating overarching plans into actionable strategies for specific areas.
Location – Poland/ Warsaw or Romania/Bucharest or Hungary/ Budapest Key Responsibilities : Providing strategic regulatory expertise for BU-led simple innovation (medicines, medical devices, cosmetics, food supplements).
Evaluating regulatory feasibility of new project ideas and identifying potential opportunities for BU-led simple innovation, based on local Regulatory Affairs and Medical input across one or more markets.
Identifying and escalating opportunities, key regulatory risks and mitigations, challenges, and resource needs associated with BU-led simple innovation.
Contribute to the development of global and/or BU /local Regulatory strategies for medicines, medical devices, cosmetics, and food supplements – ensure compliance and translate BU /global strategies into executable plans for the BU/local markets.
Why you? Basic Qualifications:
BSc Degree in a Pharmaceutical or Life Science (e.g.
Pharmacy, Bio-Sciences /Biology, Chemistry) 5 years' experience within Consumer Healthcare or Pharmaceutical industry , preferably with at least 1 year 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 comprehensive knowledge of regulatory requirements across multiple markets in CEE (medicines, medical devices, cosmetics, and food supplements).
Dossier Preparation:
Familiarity with medicines regional dossier requirements and preparing global or regional submissions.
EU Regulatory Procedures:
Proven experience in handling EU regulatory procedures (CP, DCP, MRP).
Health Authorities Interaction:
Previous experience in effective communication with external regulatory agencies and leading cross-functional responses to health authority queries.
Fluent in English - Excellent written and verbal communication skills.
P roven ability to communicate complex information to a variety of audiences in both verbal and written format.
Creative and strategic thinking, analytical and problem-solving skills.
Demonstrated experience of internal and external stakeholder s management.
Please save a copy of the j ob d escription, as this may be helpful to refer to once the advert closes.
Opportunities for growth 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 working from home, 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.
Join a supportive community that values collaboration and inclusivity and take part in integration events that foster a sense of belonging.
More detailed information will be disclosed at a further stage of recruitment process #Li-hybrid Care to join us.
Find out what life at Haleon is really like 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.
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.
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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment.
This capture of applicable transfers of value is necessary to ensure Haleon's compliance to all federal and state US Transparency requirements.
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