Regulatory Compliance Expert

1 day ago

Taguig, National Capital Region, Philippines beBeeRegulatory Full time ₱900,000 - ₱1,200,000
Regulatory Affairs Specialist Opportunity

This role presents a chance to play a critical part in ensuring the organization's compliance with regulatory requirements and facilitating the timely and successful registration of medical products. The incumbent will manage regulatory submissions, communicate with regulatory agencies, and provide regulatory guidance and support to cross-functional teams.

The ideal candidate will possess strong regulatory knowledge, project management skills, and the ability to navigate complex regulatory landscapes.

Key responsibilities include ensuring compliance with regulatory requirements throughout the product lifecycle, developing and implementing regulatory strategies, and continuously monitoring the regulatory landscape for any potential impact on the organization.

Additionally, the Local Safety Officer (LSO) duties will be performed in accordance with Global standards and local regulations.

Excellent communication and interpersonal skills are required to collaborate effectively with cross-functional teams and external stakeholders.

Required Skills and Qualifications
  • Bachelor's degree in a scientific, technical, or healthcare-related field is required; an advanced degree is preferred.
  • Minimum of 5-7 years of experience in regulatory affairs in the pharmaceutical and medical device industry, with at least 3 years in a managerial or leadership role.
  • Strong knowledge of regulatory requirements and guidelines is essential, including FDA regulations and international regulatory requirements.
  • Experienced in preparing and submitting regulatory filings, managing regulatory submissions, and interacting with regulatory agencies.
Benefits
  • Group Term life Insurance
  • Medical and Optical Reimbursement
  • Maternity assistance
  • Training and development programs
  • Engage in fun activities and team building events
About the Opportunity

Join an organization dedicated to protecting and improving global health. As a Regulatory Affairs Specialist, you will be part of a dynamic team working towards a common goal.

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