Senior Regulatory Affairs Specialist - Pharma Compliance

Aspen Philippines Inc.; Taguig; On-site; PHP 669,600 - 892,800; Full time

Job summary

A leading pharmaceutical company in Taguig seeks a Regulatory Affairs Senior Specialist to manage regulatory submissions and compliance. The ideal candidate will be a licensed pharmacist with over 7 years of experience in Regulatory Affairs. Responsibilities include preparing product dossiers, liaising with regulatory authorities, and ensuring compliance with local and international regulations. This is a full-time, on-site position offering growth in a dynamic environment.

Qualifications

• At least 7 years of experience in Regulatory Affairs.
• Experience liaising with regulatory authorities.
• Understanding of regulatory requirements and guidelines.

Responsibilities

• Prepare and submit product registration dossiers.
• Liaise with regulatory authorities to follow up on submissions.
• Organize and maintain regulatory files and records.
• Monitor updates in regulatory requirements.
• Collaborate with internal teams for regulatory purposes.
• Serve as a primary contact for regulatory authorities.

Skills

Licensed Pharmacist

Regulatory Affairs experience

Regulatory requirements understanding (FDA, ASEAN, WHO, ICH)

Education

Bachelor's degree in Pharmacy or related field

Job description

A leading pharmaceutical company in Taguig seeks a Regulatory Affairs Senior Specialist to manage regulatory submissions and compliance. The ideal candidate will be a licensed pharmacist with over 7 years of experience in Regulatory Affairs. Responsibilities include preparing product dossiers, liaising with regulatory authorities, and ensuring compliance with local and international regulations. This is a full-time, on-site position offering growth in a dynamic environment.