Job Description
- Prepare, compile, and submit regulatory documents and dossiers to health authorities (e.g., FDA, EMA) for product approvals and renewals.
- Ensure that all products comply with regulatory standards, including labeling, packaging, and advertising materials.
- Act as the main point of contact with regulatory agencies, responding to inquiries and providing necessary documentation.
- Keep abreast of changes in regulations and guidelines that may affect the company’s products and processes.
- Work closely with other departments, such as Research & Development, Quality Assurance, and Marketing, to provide regulatory guidance and support.
- Maintain accurate and comprehensive records of all regulatory activities and correspondences.
- Provide training to staff on regulatory requirements and updates.
Requirements
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field. An advanced degree is a plus.
- At least 3 years of experience in regulatory affairs, preferably in the pharmaceutical or biotechnology industry.
- Strong understanding of regulatory requirements and guidelines (FDA, EMA, etc.).
- Excellent communication and organizational skills, with attention to detail and the ability to manage multiple projects.
- Familiarity with regulatory submission software and tools.
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About PT Coolvita Maju Sehat
Learn More-
Industry
Beauty and Personal Care
Location
Tangerang Regency, Indonesia
Company Size
>100 employees
