Senior Regulatory Affairs Associate Romania - Bucharest, România - Haleon

Descriere

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.

Senior Regulatory Affairs Associate Romania & Moldova

About the role

As a Senior Regulatory Affairs Associate you will be responsible for Regulatory Affairs in defined portfolios or activity streams within Romania and Moldova.

Role Responsibilities

• To ensure products within scope (including medicines, medical devices, cosmetics and food supplements) can be placed on the market.
• To ensure products are maintained and meet internal and external compliance requirements.
• To work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges.
• To ensure engagement with the external regulatory environment including local regulators, trade associations and other key external regulatory bodies.
• Keeping relationships with Trade Associations and regulatory authorities.
• Analyzing regulatory issues and communicate with key stakeholders.
• Managing compliance within defined portfolio/activity streams in line with Haleon expectations.
• Working together with other functions (eg, quality, marketing, supply chain)
• Supporting the development of claims/advertising and promotion.
• Proactively manage impact of regulatory changes within defined scope of responsibility on the business.
• Maintain required regulatory compliance databases, systems and processes.
• Maintain high level of knowledge on the science of products within defined portfolio.

Why you?

Basic Qualifications:

• Bachelor's degree in Pharmaceutical or Life Sciences or equivalent regulatory experience.
• 3+ years' experience in regulatory affairs
• Fluent written and verbal communication in English and Romanian.
• Knowledge of regulatory submissions to markets.
• Ability to ensure compliance standards and key performance indicators are met.

Preferred Qualifications:

• Regulatory experience in the consumer healtcare is an advantage
• Regulatory expertise in knowledge of the regulatory life cycle.
• Driven by curiosity and learning agility.
• Technical knowledge.

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

What we offer?

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. 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.

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.

Diversity, Equity and Inclusion

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.

#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. 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.

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.