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Director of Regulatory Strategy

2 weeks ago

Paranaque City, Calabarzon, Philippines Faberco Life Sciences Incorporated Full time

Faberco Life Sciences Incorporated is seeking an experienced Director of Regulatory Strategy to join its team. As a key member of the regulatory team, you will be responsible for developing and implementing effective regulatory strategies to ensure compliance with FDA Philippines regulations and international standards.

About the Position

The ideal candidate will have a strong background in Regulatory Affairs, excellent communication and negotiation skills, and the ability to work effectively in a fast-paced environment. Key responsibilities include developing and implementing regulatory strategies, leading product registrations and submissions, and maintaining accurate regulatory documentation.

Key Responsibilities:

  1. Develop and implement regulatory strategies to ensure compliance with FDA Philippines regulations and international standards.
  2. Oversee the preparation, submission, and approval of product registrations and renewals.
  3. Serve as the primary contact with FDA Philippines and other regulatory authorities.
  4. Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product lifecycle.
  5. Maintain accurate and updated regulatory documentation and provide regular reports to senior management.

Requirements:

  1. Must be a licensed pharmacist in the Philippines or equivalent experience.
  2. Bachelor's degree in Pharmacy or related field; Master's degree or regulatory certification preferred.
  3. A minimum of 7-10 years of experience in Regulatory Affairs, with 3-5 years in a leadership role.
  4. Comprehensive knowledge of FDA Philippines regulations and international guidelines.
  5. Proven track record of successful product registrations and interactions with regulatory agencies.
  6. Excellent communication and negotiation skills.
  7. Strong leadership, project management, and problem-solving skills.