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Regulatory Affairs Specialist Benelux
Il y a 3 mois
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.
As Regulatory Affairs Management Professional you will be responsible for the execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for new product regulations and life-cycle maintenance.
Key Responsibilities:
Manage Chemistry, Manufacturing, and Controls (CMC) regulatory activities for new product regulations and life-cycle maintenance. Prepare registration files, clinical trials applications, variations, renewals files, and responses to Regulatory Agency inquiries. Collaborate with global colleagues and Regulatory Affairs to deliver high-quality dossiers and materials aligned with business priorities. Ensure technical congruency and regulatory compliance in partnership with authors. Update systems and procedures to maintain proper records and support controls. Provide evaluations for potential changes and ensure regulatory compliance. Communicate regulatory requirements and guidelines to facilitate timely submissions. Stay updated on guidelines, regulatory requirements, and technical trends.Basic Qualifications:
Bachelor's degree in Pharmaceutical or Life Sciences or equivalent regulatory experience. Minimum of 2 years of experience in regulatory affairs, including chemistry, manufacturing, and controls, and over-the-counter experience.Preferred Qualifications:
Knowledge of regulatory submissions to markets. Ability to ensure compliance standards and meet key performance indicators. Regulatory expertise in the knowledge of the regulatory life cycle. Ability to interact effectively at multiple levels. Technical knowledge.What we offer:
A fast-paced organizational and business environment. An opportunity to learn from a variety of healthcare products and to be exposed to European market and regulatory environments. Learning and development opportunities. Market-leading policies such as our 26-weeks equal parental leave. Highly competitive compensation and benefits package. Employee Assistance Program. 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.
