Regulatory Affairs Specialist
Global Napi Pharmaceutic...
Employer Active
Posted 13 hrs ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
- Prepare, compile, and submit regulatory dossiers for product registration in export markets (e.g., GCC, ASEAN, Africa, LATAM).
- Ensure compliance with regulatory requirements of target export countries, including labeling, product composition, packaging, and documentation.
- Coordinate with internal departments (QA/QC, R&D, Production, Supply Chain) to collect necessary data and documentation.
- Maintain and update regulatory databases and submission trackers for ongoing projects and approvals.
- Communicate with regulatory authorities, local agents/distributors, and third-party consultants for submissions, queries, and approvals.
- Bachelor s Degree in Pharmacy or Science.
- 2 4 years of proven experience in Regulatory Affairs, with a focus on export markets.
- Proficient in preparing and submitting CTD dossiers.
- Strong knowledge of international regulatory standards and documentation requirements.
- Effective communication and coordination skills with cross-functional teams and regulatory agencies.
- Moderate English proficiency, both written and spoken.
- Detail-oriented with a proactive approach to problem-solving and compliance management.
Desired Candidate Profile
- Bachelor s Degree in Pharmacy or Science.
- 2 4 years of proven experience in Regulatory Affairs, with a focus on export markets.
- Proficient in preparing and submitting CTD dossiers.
- Strong knowledge of international regulatory standards and documentation requirements.
- Effective communication and coordination skills with cross-functional teams and regulatory agencies.
- Moderate English proficiency, both written and spoken.
- Detail-oriented with a proactive approach to problem-solving and compliance management.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- R&D
- Research & Development
Keywords
- Regulatory Affairs Specialist
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Global Napi Pharmaceutic...