Regulatory Manager
2 weeks ago
About the role
As the Regulatory Manager at MedChoice Pharma, Inc., you will play a pivotal role in ensuring the company's compliance with the complex regulatory requirements of the pharmaceutical industry.
QUALIFICATIONS:
- Graduated with a Bachelor's Degree in Pharmacy
- Progressive experience in Regulatory Affairs within the Philippine pharmaceutical, medical device, or healthcare industry.
- At least 2 years in a managerial or supervisory role managing regulatory submissions and teams.
- Deep, practical knowledge of FDA Philippines administrative orders (A.O.s), circulars, and guidelines related to product registration and post-market compliance.
- Managing end-to-end alignment and coordination with multiple stakeholders to ensure the timely launch of new products.
SKILLS NEEDED:
- Strategic & Critical Thinking: Ability to analyze complex regulatory requirements and develop efficient approval protocols to ensure compliance.
- Exceptional Communication & Negotiation: Highly skilled in written and verbal communication, capable of building positive relationships with regulatory authorities, internal, and external stakeholders.
- Attention to Detail: Meticulous approach to document management, artwork reviews, and marketing material reviews.
- Project Management: Demonstrated ability to manage multiple complex projects simultaneously under strict deadlines.
- Expert Knowledge of Local Regulations
- Preferably with Importation/Exportation experience, especially in the ASEAN market.
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