Junior Regulatory Pharmacist - Global Dossier Submissions

LARGEN MED. INC.; Quezon City; Presencial; PHP 300.000 - 540.000; Jornada completa

Descripción de la vacante

LARGEN MED. INC. is seeking a Jr.

Regulatory Pharmacist to support regulatory compliance for pharmaceutical products from development through post-marketing. You will prepare, review, and submit dossiers to health authorities, ensure compliance with local and international guidelines, and assist with lifecycle management. As part of the Business Development Team, you will also explore growth opportunities with distributors and B2B/B2C channels, collaborating across R&D, QA, Marketing, and

Formación

• Bachelor’s degree in Pharmacy (BPharm) is required with no prior experience mandatory.
• Experience in regulatory affairs within the pharmaceutical industry is preferred.
• Knowledge of national and international regulatory guidelines and legislation.

Responsabilidades

• Prepare, compile, and submit regulatory dossiers (e.g., CTD format) for product registrations, renewals, and variations to health authorities.
• Ensure that all products meet the required regulations and standards (e.g., FDA, EMA, MHRA, TGA, or local authority guidelines).
• Look for potential growth partnerships that can add to the company's current lineup.
• 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 to ensure 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.

Conocimientos

Excellent written and verbal comms

Attention to detail

Organizational abilities

Educación

Bachelor’s degree in Pharmacy (BPharm)

Herramientas

eCTD software

Descripción del empleo

LARGEN MED. INC. is seeking a Jr.

Regulatory Pharmacist to support regulatory compliance for pharmaceutical products from development through post-marketing. You will prepare, review, and submit dossiers to health authorities, ensure compliance with local and international guidelines, and assist with lifecycle management. As part of the Business Development Team, you will also explore growth opportunities with distributors and B2B/B2C channels, collaborating across R&D, QA, Marketing, and