Regulatory Affairs Specialist with Life Science Expertise
1 dia atrás
About Haleon Portugal
Haleon, a new world-leading consumer health company, is seeking an experienced Regulatory Affairs Officer for its R&D department. As a key member of the team, you will play a crucial role in ensuring compliance with relevant laws and regulations.
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: Revises and approves artworks, provides input for advertising campaigns, claims, and strategy, while maintaining awareness of relevant legislation.
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.
- 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.
- Attention to detail.
- Project management experience.
- More than 5 years of experience in a similar role.
Salary Information: This role offers an estimated annual salary range of €60,000 to €80,000 depending on qualifications and experience.
About Working at Haleon:
We value our diverse workforce by creating an inclusive environment that celebrates our unique perspectives. We believe in an agile working culture for all our roles.
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