Regulatory Affairs Specialist
hace 1 semana
We are seeking a highly skilled Regulatory Affairs Analyst to join our team at Galderma, a leading dermatology company. As a Regulatory Affairs Analyst, you will play a critical role in ensuring the compliance of our products with regulatory requirements and ensuring the timely delivery of all information related to the management of regulatory procedures.
About the RoleThis is a unique opportunity to work with a dynamic team and contribute to the advancement of dermatology. As a Regulatory Affairs Analyst, you will be responsible for implementing Regulatory Affairs programs, processes, and policies to support regulatory activities related to product regulatory, Drugs CMC regulatory, Regulatory operations, and Scientific & Medical writing. You will also be responsible for tracking product safety and fulfilling regulatory requirements compliant with legislation and regulations pertaining to the business.
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.
- Implement Regulatory Affairs programs and policies for preparation, submission, and follow-up of medical affairs and authorities (MAA) and archive registration files.
- 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; gathering data, preparing, reviewing, and/or approving regulatory compliance documents; compiling, analyzing, and summarizing additional data from other sources as needed.
We are looking for a highly motivated and experienced Regulatory Affairs Analyst with a minimum of 3 years of experience in regulatory affairs. You should have a Bachelor's Degree in Pharmaceutical Chemistry and an intermediate to advanced level of English. You should also have advanced knowledge typically obtained through advanced education and work experience and contribute to process design and improvement.
About UsGalderma is a leading dermatology company with a unique legacy in dermatology and decades of cutting-edge innovation. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. We are committed to advancing dermatology for every skin story and empowering our employees to grow and develop in their careers.
We are an equal opportunities employer and welcome applications from diverse candidates. If you are passionate about doing something meaningful for consumers, patients, and healthcare professionals, we encourage you to apply for this exciting opportunity.
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