Export DRA Specialist
Orchidia Pharmaceutical ...
Employer Active
Posted 18 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 export markets in compliance with international and local regulations.
- Monitor and interpret evolving regulatory requirements in target export countries to ensure ongoing compliance.
- Coordinate with cross-functional teams (R&D, Quality Assurance, Production) to gather and validate required documentation for regulatory submissions.
- Liaise with regulatory authorities, agents, and distributors in export markets to facilitate product registrations and approvals.
- Maintain up-to-date records of regulatory submissions, approvals, and correspondence for all export markets.
- Review and approve product labeling, packaging, and promotional materials to ensure regulatory compliance.
- Support the timely renewal of product registrations and licenses in international markets.
- Identify and resolve regulatory issues that may impact product export or market entry.
- Provide regulatory guidance and training to internal teams regarding export requirements and best practices.
- Track and report on the status of regulatory submissions and approvals to management.
Desired Candidate Profile
- Bachelor s degree in Pharmacy, Pharmaceutical Sciences, or a related field.
- 1-3 years of experience in regulatory affairs, preferably within the pharmaceutical industry.
- Familiarity with international regulatory guidelines (e.g., ICH, WHO, FDA, EMA) and export procedures.
- Strong understanding of pharmaceutical documentation and dossier preparation.
- Excellent communication and interpersonal skills for effective liaison with regulatory authorities and internal teams.
- Detail-oriented with strong organizational and time management abilities.
- Proficiency in Microsoft Office Suite and regulatory submission platforms.
- Ability to work independently and collaboratively in a fast-paced environment.
- Fluency in English; additional languages are an asset.
- Willingness to stay updated on changes in global regulatory requirements.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Doctor
- Nurse
- Paramedics
- Hospital Technicians
- Medical Research
Keywords
- Export DRA Specialist
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Orchidia Pharmaceutical ...