Dermatology Regulatory Specialist
hace 2 semanas
About the Role: We are seeking a highly skilled Regulatory Affairs Coordinator to join our team at Galderma.
Key Responsibilities:
We are looking for a detail-oriented and proactive individual to assist in the implementation of Regulatory Affairs programs, processes, and policies. This includes supporting regulatory activities related to product regulatory, Drugs CMC regulatory, Regulatory operations, and Scientific & Medical writing on both new and in-line products.
Duties and Responsibilities:
- Implement Regulatory Affairs programs, processes, and policies to support regulatory activities related to product regulatory, Drugs CMC regulatory, Regulatory operations, and Scientific & Medical writing on both new and in-line products.
- Prepare, submit, and follow-up on medical affairs and authorities (MAA) and archive registration files.
- Assist in 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.
- Track product safety and fulfill regulatory requirements compliant with legislation and regulations pertaining to the business.
- Implement Regulatory Affairs plans and processes for all activities related to Regulatory reporting/documentation for internal and external audiences.
- Assist in preparing literature for new products and revising existing literature.
Requirements:
We are looking for a candidate with a Master's / Bachelor's Degree or equivalent experience/qualification in a relevant field. The ideal candidate will have at least 4 years of experience in Regulatory Affairs, preferably in Peru, Ecuador, Bolivia, Venezuela, or Cono Sur. They should also have experience in the pharmaceutical, cosmetic, and/or medical device industry and possess high ethical standards.
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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