Regulatory Affairs Specialist
hace 2 semanas
Company Overview: Galderma is a global leader in dermatology, dedicated to advancing the science of skin health. With a presence in around 90 countries, we focus on delivering innovative products and services across various dermatological segments, including Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology.
Position Overview: The Regulatory Affairs Coordinator will play a pivotal role in implementing and managing regulatory programs, processes, and policies that support compliance with health authority regulations. This position encompasses a wide range of responsibilities related to product regulation, including biologicals, chemical drugs, medical devices, and cosmetics.
Key Responsibilities:
- Develop and execute Regulatory Affairs programs and policies to facilitate regulatory activities for product categories, ensuring compliance with applicable regulations.
- Prepare, submit, and manage medical affairs and authority registration files, maintaining thorough documentation.
- Assist in the creation and editing of clinical study manuscripts and scientific reports, ensuring clarity and accuracy for regulatory submissions.
- Monitor product safety and ensure adherence to regulatory requirements, fulfilling all legislative obligations.
- Coordinate Regulatory reporting and documentation processes for both internal and external stakeholders, compiling and analyzing necessary data.
- Support the preparation of literature for new products and update existing materials as needed.
Qualifications:
Education: A Master's or Bachelor's Degree in a relevant field or equivalent experience.
Experience: A minimum of 4 years of recent experience in Regulatory Affairs, preferably within the pharmaceutical, cosmetic, or medical device industries, with knowledge of regulations in the South American region.
Skills:
- Strong ethical standards and integrity.
- Comprehensive understanding of legislation governing drugs, cosmetics, and medical devices.
- Ability to work collaboratively in a team environment.
- Strategic vision and independent work capability.
Employer's Note: This job description is intended to provide a general overview of the position. Additional duties may be assigned as necessary, and the employer reserves the right to modify this description at any time.
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