Regulatory Affairs Assistant Manager
2 weeks ago
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. 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. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story.
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 promote their personal growth 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 bold 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 an unparalleled, direct impact.
Responsibilities:
- Complete all regulatory submissions (NPD and renewal) and follow up until approval in accordance with the business timeline- Complete the pre-registration activities, e.g. review of regulatory requirements, agency communication and discussion to ensure timely submission- Ensure product lifecycle management compliance and submit the variations to Government Authorities in timely manner and implement the change within the defined timeline-
- Review the regulatory artworks and promotional materials in regulatory perspective- Organize, update and maintain regulatory information, tracking and repository in timely manner- Develop, maintain good relationship with Government Authorities, and keep company updated about governmental rules and regulations that will impact on company business- Submit the response of inquiries and information requests from Government Authorities in timely manner- Develop, review and revise regulatory SOPs and procedures as assigned- Perform other special projects as assigned
Requirement:
- Pharmacist with a license- 3-5 years experiences in regulatory affairs experience in medical devices or/and drugs / cosmetics product- Fluent/communicable in English
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