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, delivering a diverse range of premium brands and services in the dermatology sector, including Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our inception in 1981, we have focused on enhancing the health and well-being of individuals through superior skin care solutions.
Position Objective:
The primary goal of this role is to implement comprehensive Regulatory Affairs initiatives, processes, and policies that facilitate regulatory activities concerning product compliance (Biologicals, chemical drugs, and medical devices), Drugs CMC regulatory, Regulatory operations, and Scientific & Medical writing for both new and existing products, adhering to the standards set by health authorities.
Key Responsibilities:
- Develop and execute Regulatory Affairs programs and policies to support regulatory activities related to product compliance (Biologicals, chemical drugs, and medical devices), Drugs CMC regulatory, Regulatory operations, and Scientific & Medical writing for both new and existing products, in line with health authority regulations.
- Establish and maintain Regulatory Affairs programs for the preparation, submission, and follow-up of medical affairs and authority applications (MAA), as well as the organization of registration files.
- Monitor product safety and ensure compliance with regulatory requirements as per applicable legislation and regulations.
- Implement Regulatory Affairs strategies and processes for all activities related to regulatory documentation for both internal and external stakeholders; this includes data gathering, document preparation, review, and approval of regulatory compliance documents, as well as compiling and analyzing data from various sources as necessary.
- Oversee the operations of the Regulatory Affairs department in the designated regions.
- Ensure timely communication of all information related to the management of regulatory procedures that must be submitted to the health authorities in the assigned regions.
Qualifications:
The ideal candidate will possess a minimum of 3 years of experience in regulatory affairs and hold a Bachelor's Degree in Pharmaceutical Chemistry. A proficiency in English at an intermediate to advanced level is required.
Professional Attributes:
We seek individuals who demonstrate advanced knowledge typically acquired through higher education and relevant work experience. Candidates should be adept at contributing to process design and improvement initiatives.
Employer's Rights:
This job description does not encompass all duties associated with the position. Supervisors or managers may assign additional responsibilities. Employee performance will be evaluated based on the execution of the tasks outlined in this description. The employer reserves the right to modify this job description at any time. This document does not constitute an employment contract, and either party may terminate employment at any time for any reason. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.
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