Regulatory - Affair

Pemasaran Media

- 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. - 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.