Job Description Summary

Job Description

Job Description Summary:
We are looking for a highly motivated individual to join our team as Regulatory Affairs Specialist/Manager in the Pharmaceuticals Division. The successful candidate will be responsible for obtaining regulatory approval of new products and maintaining existing licenses in line with local regulations, while ensuring compliance with all relevant laws and regulations. This role will involve collaborating closely with cross-functional teams to ensure timely and effective product launches, as well as ongoing support for marketed products. The position requires excellent organizational skills, attention to detail, and strong communication abilities.

Job Responsibilities:
· Lead and coordinate regulatory activities related to drug registration, including preparation of required documents and submission to authorities.
· Collaborate with internal stakeholders such as R&D, Manufacturing, Quality Assurance, Marketing and Sales to gather information necessary for regulatory submissions.
· Ensure compliance with all relevant regulations and guidelines, including GCP standards.
· Stay updated on changes in regulatory requirements and guidance documents, and implement appropriate measures to address any impacts on current or future registrations.
· Maintain accurate records of all regulatory documentation, including filings, correspondence, and inspection reports.
· Support preparation and review of promotional materials to ensure compliance with regulatory requirements.
· Coordinate interactions with regulators during site visits or meetings, providing clear and concise explanations of technical aspects related to product registration.
· Work closely with external consultants and experts to facilitate smooth progress of registration process.
· Provide regular updates to management regarding status of registration activities.

Job Qualifications:
· Bachelor's degree (or equivalent) in pharmacy, biology, chemistry, biochemistry, or other relevant discipline. Advanced education in regulatory affairs or similar field preferred but not mandatory.
· Minimum of five years of experience in pharmaceutical industry, preferably in a regulatory affairs or quality assurance role. Experience working within a government agency or academic institution would also be beneficial.
· Strong understanding of regulatory frameworks governing pharmaceutical products, ideally including knowledge of Japanese regulatory requirements.
· Excellent written and verbal communication skills in English and Japanese.
· Ability to work independently and handle multiple tasks simultaneously.
· Detail-oriented and able to manage complex data sets and processes.
· Proficiency in using computer systems and software applications commonly used in regulatory affairs, including document management tools.
· Knowledge of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).

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