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.
About the role
Haleon Portugal is looking for a Regulatory Affairs Officer Position belonging to the R&D department and reporting to the Portugal Regulatory Affairs Lead.
Importance of the function within the company:
Regulatory affairs play a crucial role in the consumer healthcare sector where Haleon operates. This function ensures compliance with all relevant laws and regulations, including local, national, and international standards, which helps avoid legal issues, fines, and penalties.
Regulatory affairs professionals are responsible for obtaining the necessary registrations and approvals to bring new products to market, involving license maintenance activities and regulatory compliance for medicinal and non-medicinal products. They also ensure that product labelling and advertising are accurate and comply with regulatory standards, maintaining consumer trust and avoiding misleading claims.
Additionally, regulatory affairs work closely with quality assurance teams to ensure that manufacturing processes meet regulatory standards, helping maintain product quality and consistency. A strong regulatory affairs team can provide a strategic advantage by ensuring faster approval times and smoother market entry.
After a product is on the market, regulatory affairs continue to monitor its performance, tracking adverse events, updating labelling, and ensuring ongoing compliance with regulations.
They also act as a bridge between the company and regulatory bodies, communicating with other stakeholders, including healthcare professionals, consumers, and internal teams, to ensure everyone is informed about regulatory requirements and changes.
Key responsibilities
Dossier Preparation and Submission: Prepares and submits dossiers to the Portuguese Health Authorities for medicines, cosmetics, medical devices, and food supplements.
Regulatory Communication: Manages communication with Portuguese Health Authorities and Competent Authorities for various product categories.
Medicines life cycle management: Oversees renewals, variations, new product launches, and variation implementation projects.
Scientific and Regulatory Documentation: Develops and submits scientific information for OTC classification, elaborates SmPCs, leaflets, and artworks, and coordinates with Global and Category Regulatory teams for dossier submissions.
Support and Compliance: Provides regulatory strategy and claims support to Local Business and Global RA, supports marketing with strategic information, and ensures compliance with legislation and internal processes.
Artwork and Promotional Material Review: Revises and approves artworks, provides input for advertising campaigns, claims and strategy, while maintaining awareness of relevant legislation.
Administrative support activities: national product codes, notification of promotional materials and events.
Qualifications and skills
License degree or Integrated Master in Life science/Pharmaceutically related science (Pharmacy, Pharmaceutical science).
Excellent knowledge of spoken and written English.
Excellent knowledge of office IT tools.
General knowledge of the pharmaceutical industry.
Good knowledge of Portuguese pharmaceutical, cosmetic, medical device, and food supplements legislation.
Good knowledge and relationship with Health Authorities.
Preferred
Effective communication.
Excellent capability of critical and analytical thinking.
More than 5 years of experience in a similar role.
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 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.
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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