Hello. We're Haleon, a new world-leading consumer health company. 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. This is an exciting time to join us and help shape the future.
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. 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.
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.
Compliance with internal processes and procedures and maintenance of key databases.
Administrative support activities: national product codes, notification of promotional materials, and events.
Qualifications and Skills Essential 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 critic and analytical thinking.
Attention to detail.
Project management experience.
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. 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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