Regulatory Affairs Officer

2 days ago

Bonifacio Global Metro Manila, Philippines SRS Life Sciences Full time ₱1,200,000 - ₱2,500,000 per year

JOB PURPOSE

We are seeking a experienced Regulatory Affairs Officer with comprehensive knowledge of regulatory processes and at least 5 years of experience in preparing and managing drug dossiers.

As Regulatory Affairs Officer, you will play a critical role in ensuring that our Drug, Medical Device, Food Supplements and Cosmetic products adhere to all applicable regulations and standards, including ICH requirements and regional requirements. This role requires a deep understanding of regulatory guidelines and the ability to effectively communicate with regulatory authorities, cross-functional teams, and external partners. This role involves coordinating, documenting, compiling, and preparing dossiers for submission to regulatory agencies. The ideal candidate will be detail-oriented, proactive, and capable of managing multiple projects to ensure successful regulatory submissions, approvals and compliance.

Tasks and Requirements:

  • Familiarity and experience with Drugs, Food Products, Food supplements, Herbal, Traditional medicines, Pre-biotics, Probiotics, devices, and other hospital / healthcare practices.
  • Knowledge of standard office software programs including e-dossier management system, spreadsheet, word-processing, email applications, and PowerPoint.
  • Substantial experience and understanding of the role of RA and regulatory requirements in the Life Sciences Industry including ICH requirements and regional requirements and understanding of current trends in the local market.
  • Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
  • Good project management skills with the ability to prioritize and multitask.
  • Strong collaborative skills and ability to work well with internal cross-functional teams and external stakeholders.
  • Excellent decision-making skills: make important decisions that impact the department and ensure they are proactively and appropriately communicated.
  • Good communication skills, especially as it relates to transparency, collaboration, and the ability to work across communication channels.
  • Self-motivated, able to work independently, enjoy a good challenge, and remains focused even in the face of setbacks.
  • A flexible "can do" attitude is needed to thrive in an ambitious and fast-growing company.
  • Flexible, determined, eager to experiment, and has an open mind.
  • Showing initiative and ownership in their work to ensure a independent and reliable way of working
  • High levels of integrity and honesty.

Minimum Qualification: Bachelor's in Pharmacy/Pharmacology, with registered license.

Additional Qualification (preferred): Master of Science in Pharmacy

Years of Experience: Minimum 4-5 years in Pharmaceutical companies

Language Preference: English

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