Global Regulatory Affairs Specialist — Hybrid/Remote

Datwyler; Hinoba-an; Hybrid; PHP 446,000 - 893,000; Full time

Job summary

Datwyler is seeking a Regulatory Affairs Specialist to support drug master file references, validation washings, and standard provisions. You will coordinate LOA requests for FDA, Health Canada, and NMPA, maintain LOA data, and assist in dossier preparation and annual DMF reports.

The role involves global collaboration with R&D, QA, and sales teams, with partial remote work after training and occasional travel to ensure compliance across regions.

Qualifications

• Master or Bachelor degree in a scientific discipline with industry experience in RA/QA/R&D.
• Exposure to packaging components or pharmaceutical industry is a plus.
• Strong written and spoken English; able to coordinate with global teams.

Responsibilities

• Assess LOA requests to reference DMFs for drug approvals and support validation activities.
• Prepare LOA drafts for US FDA, Health Canada, and NMPA China.
• Maintain LOA data and share analyses with sales teams as required.
• Prepare weekly DMF data packages and support annual DMF reports.
• Help ensure availability of washing validation reports and submission formats.

Skills

English proficiency

Regulatory affairs experience

Dossier preparation (eCTD)

Global coordination

Education

Bachelor or Master in scientific field

Tools

eCTD software

Regulatory databases

Job description

Datwyler is seeking a Regulatory Affairs Specialist to support drug master file references, validation washings, and standard provisions. You will coordinate LOA requests for FDA, Health Canada, and NMPA, maintain LOA data, and assist in dossier preparation and annual DMF reports.

The role involves global collaboration with R&D, QA, and sales teams, with partial remote work after training and occasional travel to ensure compliance across regions.