Regulatory Compliance Specialist
hace 2 semanas
Company Overview:
Galderma stands as a leader in dermatology, boasting a rich history and a commitment to innovation. Our presence spans approximately 90 countries, offering a diverse range of premium brands and services across Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Our mission is to enhance the health and beauty of skin, catering to the needs of consumers and healthcare professionals alike.
Position Overview:
The primary objective of this role is to implement and manage Regulatory Affairs programs, processes, and policies that support various regulatory activities. This includes oversight of product regulations related to Biologicals, chemical drugs, and medical devices, as well as Drugs CMC regulatory and Scientific & Medical writing for both new and existing products, ensuring compliance with health authority standards.
Key Responsibilities:
- Develop and execute Regulatory Affairs strategies to facilitate compliance with product regulations, including Biologicals, chemical drugs, and medical devices.
- Prepare, submit, and maintain medical affairs documentation and registration files in accordance with regulatory requirements.
- Monitor product safety and ensure adherence to applicable legislation and regulations.
- Coordinate all activities related to Regulatory reporting and documentation for both internal and external stakeholders, including data gathering and regulatory compliance documentation.
- Manage the operational aspects of Regulatory Affairs within designated regions, ensuring timely communication of regulatory procedures to health authorities.
Qualifications:
- A minimum of 3 years of experience in regulatory affairs.
- Bachelor's Degree in Pharmaceutical Chemistry or a related field.
- Intermediate to advanced proficiency in English.
Professional Attributes:
The ideal candidate will possess advanced knowledge gained through education and relevant work experience, contributing to process design and improvement initiatives within the Regulatory Affairs domain.
Employer's Note:
This job description outlines the primary duties of the position but is not exhaustive. Additional responsibilities may be assigned as needed. The employer reserves the right to modify this job description at any time.
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