Regulatory Affairs Director
2 days ago
Cobden & Carter International is seeking a highly skilled and experienced Regulatory Affairs Head to lead our Regulatory Affairs team in ensuring compliance with applicable regulations in the Philippines.
Key Responsibilities:- Develop and implement regulatory strategies to ensure compliance with FDA Philippines regulations and international standards.
- Oversee the preparation, submission, and approval of product registrations and renewals.
- Establish and maintain relationships with regulatory agencies, including the FDA Philippines.
- Collaborate with cross-functional teams 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.
- 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.
- Must be a licensed pharmacist in the Philippines.
- Bachelor's degree in Pharmacy or a related field. A Master's 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.
Location: Paranaque
Set-up: Onsite 100%
Shift: Dayshift
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