Operational Regulatory Specialist
4 days ago
As a Senior Operational Regulatory Affairs Consultant, you will be responsible for:
- Developing and implementing regulatory strategies for market entry and product registration.
- Providing regulatory support and intelligence to clients, ensuring compliance with local and regional health authorities.
- Managing the submission process for dossiers to local or regional health authorities and following up on post-approval commitments.
- Assisting in maintaining the Quality Management System, particularly in Good Distribution/Storage and Supply Practices for Marketing Authorization Holding.
- Participating in business development and project execution related to regulatory affairs, pharmacovigilance, and quality assurance.
Requirements:
- Bachelor's Degree in Pharmacy or a related field.
- Minimum 2-3 years of experience in regulatory affairs, product registration, submissions to regulatory authorities, pharmacovigilance, and Quality System maintenance.
- Entrepreneurial mindset, problem-solving skills, self-driven, mature, and able to work independently or in dynamic environments.
- Ability to manage projects to completion within allocated timelines.
- Resourcefulness in seeking answers to challenging questions regarding the Philippines Regulatory environment.
- Fluency in business English and proficiency in the Philippines language required, both spoken and written, with international experience.
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