Regulatory Affairs Manager
hace 6 días
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.
**Job Description**:
Localisation: Santiago, Chile
Mission:
Provide input to and lead implementation of Regulatory Affairs plans and programs to manage activities related to product regulatory (Biologicals, chemical drugs and medical devices), Drugs CMC regulatory, Regulatory operations and Scientific & Medical writing on both new and in-line products, in accordance with health authorities. Main representative (sanitary responsible) in front of the local regulatory entity (Instituto de Salud Pública de Chile).
Main responsibilities:
- Provide input to and lead implementation of Regulatory Affairs plans and programs to manage activities related to product regulatory (Biologicals, chemical drugs and medical devices), Drugs CMC regulatory, Regulatory operations and Scientific & Medical writing on both new and in-line products, in accordance with health authorities
- Manage Regulatory Affairs programs and policies for preparation, submission and follow-up of medical affairs and authorities (MAA) and archive registration files
- Develop programs for writing and editing manuscripts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication
- Monitor product safety and fulfil the regulatory requirements compliant with legislation and regulations pertaining to the business
- Monitor regulatory developments and determine the impact on business operations and compliance programs+
Education: chemical-pharmaceutical master degree.
Experience: 5 years in Regulatory Affairs and Quality assurance in farmaceutical company.
Employer’s Rights:
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
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