Regulatory Pharmacist, Pasig

• Elixir Pharma Inc. is looking for a Regulatory Pharmacist to strengthen our compliance and regulatory affairs team.
• The role involves handling the preparation and submission of regulatory documents for drugs, food supplements, and cosmetics, ensuring full compliance with FDA requirements.
• This is an excellent opportunity for a licensed pharmacist with 35 years of regulatory experience to build a solid career in a reputable pharmaceutical company based in Ortigas Center, Pasig City. 

Skills Requirements

• Strong knowledge of FDA regulations and compliance requirements for drugs, food   supplements, and cosmetics
• Proficient in preparing, reviewing, and filing regulatory submissions (LTO, CPR, product registration, renewals, amendments)
• Excellent attention to detail and documentation accuracy
• Strong organizational and time management skills to handle multiple filings and deadlines
• Ability to interpret and apply regulatory guidelines, circulars, and advisories
• Effective communication and coordination skills with internal teams (QA, R&D, Sales) and external stakeholders (FDA, suppliers)
• Problem-solving skills in addressing regulatory queries, deficiencies, or rejections
• Proficient in MS Office applications (Word, Excel, PowerPoint) and basic familiarity with online regulatory portals
• Ability to work independently and collaboratively in a fast-paced environment
• High level of professionalism and integrity in handling confidential documents