Regulatory Affairs Director
3 weeks ago
The Regulatory Affairs Director will lead our team in ensuring compliance with pharmaceutical regulations in the Philippines.
Responsibilities- Oversee regulatory submissions and manage relationships with FDA Philippines.
- Ensure product registrations and renewals comply with local and international laws.
- Act as primary contact with regulatory authorities, including FDA Philippines.
- Collaborate with Business Development and Marketing teams to ensure regulatory requirements are met.
- Manage product registration, ensuring timely renewals and compliance.
- Maintain accurate regulatory documentation and provide regular reports to senior management.
- Lead and mentor the Regulatory Affairs team, promoting high performance and regulatory expertise.
- Regulatory Compliance
- Regulatory Agency Relationship
- Product Registration Management
- Audit & Inspection Readiness
- Licensed pharmacist in the Philippines
- Bachelor's degree in Pharmacy or a related field; Master's degree or regulatory certification preferred
- At least 7-10 years of experience in Regulatory Affairs, with 3-5 years in a leadership role, preferably in the pharmaceutical industry
- Comprehensive knowledge of FDA Philippines regulations and international guidelines
- Proven track record of successful product registrations and interactions with regulatory agencies
Location: Paranaque
Set-up: Onsite 100%
Shift: Dayshift
The estimated annual salary for this position is PHP 2,500,000 - PHP 4,000,000, depending on qualifications and experience.
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