Regulatory Affairs Head

Role:

The Regulatory Affairs Head is responsible for leading and managing the Regulatory Affairs team in ensuring that all pharmaceutical products comply with applicable regulations in the Philippines. This role involves overseeing regulatory submissions, managing relationships with regulatory agencies such as the Food and Drug Administration (FDA) Philippines, and ensuring that the company adheres to all local and international laws, regulations, and standards for pharmaceutical products.

Responsibilities:

• Ensure all products and activities of the company comply with FDA Philippines regulations and international standards.
• Oversee the preparation, submission, and approval of product registrations and renewals.
• Act as the primary contact with FDA Philippines and other regulatory authorities.
• Work closely with BD and Marketing to ensure regulatory requirements are met at all stages of product development and commercialization.
• Manage the regulatory aspects of product registration, ensuring timely renewals and compliance.
• Maintain accurate and updated regulatory documentation and provide regular reports to senior management.
• Lead and mentor the Regulatory Affairs team, ensuring high performance and regulatory expertise.
• Identify and mitigate regulatory risks to ensure continued product compliance and market access.

Key Accountabilities:

• Regulatory Compliance
• Regulatory Agency Relationship
• Product Registration Management
• Audit & Inspection Readiness

Qualifications:

• Must be a licensed pharmacist in the Philippines.
• Bachelors degree in Pharmacy or a related field. A Masters degree or regulatory certification is preferred.
• At least 7-10 years of experience in Regulatory Affairs, with a minimum of 3-5 years in a leadership role, preferably in the pharmaceutical industry.
• Comprehensive knowledge of FDA Philippines regulations and international regulatory guidelines.
• Proven track record of successful product registrations and interactions with regulatory agencies.

Work Setup:

Location: Paranaque

Set-up: Onsite 100%

Shift: Dayshift

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