Operational Regulatory Specialist

4 days ago


Manila, National Capital Region, Philippines PharmEng Nordic ApS Full time
Key Responsibilities:

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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