Regulatory Affairs Pharmacist

A Pharmacist License, and at least 3 years of experience in Regulatory Affairs, specifically with ACTD experience.

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.
• Others

A Pharmacist License, and at least 3 years of experience in Regulatory Affairs, specifically with ACTD experience.

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.
• Others