Regulatory Affairs Expert for Consumer Healthcare
2 semanas atrás
At Haleon, we're shaping the future of consumer healthcare by combining deep human understanding with trusted science. Our portfolio includes category-leading brands such as Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum.
About the RoleWe're seeking a Regulatory Affairs Officer to join our R&D department in Portugal, reporting to the Portugal Regulatory Affairs Lead. This is an exciting opportunity to contribute to the success of our business.
The successful candidate will be responsible for ensuring compliance with all relevant laws and regulations, including local, national, and international standards. They will obtain necessary registrations and approvals for new products, manage license maintenance activities, and ensure regulatory compliance for medicinal and non-medicinal products.
This role requires excellent knowledge of spoken and written English, office IT tools, and general knowledge of the pharmaceutical industry. A good understanding of Portuguese pharmaceutical, cosmetic, medical device, and food supplements legislation is also essential.
A strong background in life science or pharmaceutically related sciences, such as pharmacy or pharmaceutical science, is required. The ideal candidate should have effective communication skills, critical and analytical thinking, attention to detail, and project management experience.
Key Responsibilities- Dossier Preparation and Submission: Prepare and submit dossiers to the Portuguese Health Authorities for medicines, cosmetics, medical devices, and food supplements.
- Regulatory Communication: Manage communication with Portuguese Health Authorities and Competent Authorities for various product categories.
- Medicines Life Cycle Management: Oversee renewals, variations, new product launches, and variation implementation projects.
- Scientific and Regulatory Documentation: Develop and submit scientific information for OTC classification, elaborate SmPCs, leaflets, and artworks, and coordinate with Global and Category Regulatory teams for dossier submissions.
- Support and Compliance: Provide regulatory strategy and claims support to Local Business and Global RA, support marketing with strategic information, and ensure compliance with legislation and internal processes.
- Artwork and Promotional Material Review: Revise and approve artworks, provide input for advertising campaigns, claims, and strategy, while maintaining awareness of relevant legislation.
- Compliance with Internal Processes and Procedures and Maintenance of Key Databases.
- Essential Qualifications:
- License degree or Integrated Master
- Life science/Pharmaceutically related science (Pharmacy, Pharmaceutical science)
- Excellent Knowledge:
- Spoken and written English
- Office IT tools
- General knowledge of the pharmaceutical industry
- Good knowledge of Portuguese pharmaceutical, cosmetic, medical device, and food supplements legislation
- Preferred Qualifications:
- Effective communication
- Critical and analytical thinking
- Attention to detail
- Project management experience
The estimated salary for this position ranges from €55,000 to €80,000 per annum, depending on qualifications and experience.
Benefits and Working ConditionsHaleon offers a dynamic and inclusive work environment with opportunities for career growth and professional development. We strive to create a climate where diversity is celebrated, and everyone feels valued and supported.
Please note that this job description is subject to change based on business needs.
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