Regulatory Pharmacist - Dossier & Growth Lead

LARGEN MED. INC.; Quezon City; On-site; PHP 600,000 - 900,000; Full time

Job summary

LARGEN MED. INC. in the Philippines seeks a Regulatory Pharmacist to oversee regulatory compliance of pharmaceutical products from development through post-marketing. You will prepare, review, and submit dossiers to health authorities and advise on regulatory strategy.

You will collaborate with R&D, QA, Marketing, and Manufacturing, monitor regulatory changes, maintain files, and support partnerships with distributors and B2B/B2C channels to grow the business.

Qualifications

• Excellent written and verbal communication skills.
• Strong attention to detail and organizational abilities.
• Prior experience in regulatory affairs within the pharmaceutical industry.
• Knowledge of national and international regulatory guidelines and legislation.

Responsibilities

• Prepare, compile, and submit regulatory dossiers (CTD format) for product registrations, renewals, and variations to health authorities.
• Ensure products meet required regulations and standards (FDA, EMA, MHRA, TGA, or local guidelines).
• Look for potential growth partnerships with distributors, B2B and B2C channels.
• Liaise with national and international regulatory agencies to facilitate approvals.
• Provide regulatory input during product development and clinical trial planning.
• Monitor changes in regulations and advise internal teams on compliance implications.
• Review product labeling, promotional materials, and packaging for regulatory compliance.
• Maintain regulatory files and databases for easy retrieval and reference.
• Participate in audits and inspections as a regulatory representative.
• Collaborate with cross-functional teams including R&D, Quality Assurance, Marketing, and Manufacturing.

Skills

Communication skills

Attention to detail

Organizational abilities

Regulatory affairs experience

RAC (Desirable)

Education

BPharm / PharmD or equivalent

Tools

eCTD software

Job description

LARGEN MED. INC. in the Philippines seeks a Regulatory Pharmacist to oversee regulatory compliance of pharmaceutical products from development through post-marketing. You will prepare, review, and submit dossiers to health authorities and advise on regulatory strategy.

You will collaborate with R&D, QA, Marketing, and Manufacturing, monitor regulatory changes, maintain files, and support partnerships with distributors and B2B/B2C channels to grow the business.