A Pharmacist License, and at least 3 years of experience in Regulatory Affairs, specifically with ACTD experience.
The candidate should have a strong understanding of the Philippine regulatory environment, as well as knowledge of ASEAN and international regulations and guidelines.
Excellent communication, interpersonal, and project management skills are also essential for success in this role
- Developing and implementing regulatory strategies for the registration of new & existing pharmaceutical products in the Philippines.
- Preparing and submitting ACTD dossiers to regulatory agencies in the Philippines.
- Communicating and negotiating with regulatory authorities to ensure timely approval of applications and timely resolution of any issues related to product registration.
- Providing regulatory guidance and advice to cross-functional teams involved in product development, manufacturing, and quality assurance.
- Ensuring compliance with regulatory requirements for product labeling, advertising, and promotional activities.
- Conducting regulatory assessments and gap analyses to identify potential regulatory risks and recommend appropriate mitigation strategies.
- Keeping up-to-date with changes in local and international regulations and guidelines that may impact product development, registration, or marketing.
- Managing regulatory submissions and maintaining regulatory documentation in compliance with local and international standards.
- Providing support for regulatory inspections and audits conducted by regulatory agencies.
- Participating in cross-functional teams to develop and implement post-marketing surveillance programs for pharmaceutical products.
