Job Requirements:
1. Educational Qualifications: Bachelor's degree in Pharmacy or a related field. A Master's degree is a plus.
2. Experience:
• Minimum 5 years of experience in the pharmaceutical industry, with expertise in regulatory submissions and product registration.
• Proficient in preparing ASEAN Common Technical Dossiers (ACTD) and expert with Philippine FDA regulations.
• Experience coordinating with international stakeholders, particularly in India and Southeast Asia.
3. Technical Skills:
• Strong grasp of ICH guidelines, GMP, GLP, clinical trials, and bioequivalence requirements.
• Skilled in compiling technical documentation such as product development reports, validation reports, and PMS data.
• Adept in labeling and artwork review, pre-shipment approvals, and complaint resolution (CAPA).
4. Soft Skills:
• Excellent analytical skills and attention to detail.
• Strong organizational, coordination, and time-management capabilities.
• Fluent in English and Hindi, with proven ability to communicate effectively across multicultural teams.
5. Skills: Excellent communication and relationship-building skills with physicians, pharmacies, and distributors.