Regulatory Affairs Director

7 days ago


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

The Regulatory Affairs Director at Faberco Life Sciences Incorporated is responsible for leading the company's regulatory efforts to ensure compliance with applicable laws, regulations, and standards in the pharmaceutical industry.

About the Role

This is a challenging and rewarding opportunity for an experienced professional to lead the development and implementation of effective regulatory strategies. The successful candidate will be responsible for overseeing all aspects of regulatory affairs, including product registrations, renewals, and submissions.

Key Responsibilities:

  1. Develop and implement regulatory strategies to ensure compliance with FDA Philippines regulations and international standards.
  2. Lead 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.
  6. Leverage expertise to identify and mitigate regulatory risks and ensure continued market access.

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.


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