Department: Regulatory Affairs
Gender: Male/Female
Roles & Responsibilities:
- Prepare, compile, and submit regulatory documents to health authorities (e.g., FDA, EMA, MOH) for product approvals, renewals, and variations.
- Ensure submissions are accurate, complete, and timely.
- Ensure compliance with local, national, and international regulations and standards for pharmaceutical products.
- Stay updated on regulatory guideline changes and inform relevant departments.
- Manage the registration of new products in various markets.
- Liaise with health authorities and regulatory agencies for product approvals.
- Collaborate with R&D, quality assurance, manufacturing, and marketing teams to meet regulatory standards.
- Monitor the regulatory environment and assess impacts on the company’s products.
- Maintain and update regulatory documentation, including technical files and product dossiers.
Key Skills
- Knowledge of regulatory market
- Analytical skills
- Time management
- Problem-solving skills
- Attention to detail
- Communication skills
Qualifications
- Any graduate with B.Pharm / M.Pharm / M.Sc. or any relevant degree in Pharmaceuticals
Interested person can send their resume to us hr@salvavidashpharma.com
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