Regulatory Affairs Specialist
3 weeks ago
Regulatory Affairs Associate
This role is responsible for overseeing regulatory activities for assigned medicines, medical devices, cosmetics, and/or food supplements within their geographical and/or brand area of responsibility.
Key Responsibilities
- Assists in the coordination, compilation, and submission of new drug applications, cosmetics, medical devices, food supplements, or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility.
- Collects and organizes information on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
- Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
- Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.
- Prioritizes, plans, and monitors allocated projects against defined timelines.
- Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements.
Regulatory Compliance
- Assists in the maintenance of compliance for all products with local regulations and quality system requirements.
- Ensures that all assigned products comply with local regulatory and quality system requirements.
- Reviews and approves promotional materials for assigned local Kenvue products.
- Initiates, reviews, and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
- Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
- Identifies and initiates local process improvement opportunities and manages changes as required.
- Assists in the preparation for internal and external audits and inspections in collaboration with others.
Qualifications
- Relevant Bachelor's Degree or higher.
- 2+ years related regulatory experience.
- Knowledge of consumer healthcare environment and product development.
- Understanding of processes and departments within a healthcare company.
- Effective time and organization management.
- Full proficiency in both Swedish and English.
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