Regulatory Affairs Associate

The Regulatory Affairs Associate is responsible for supporting the regulatory affairs team in ensuring the company's products comply with local regulatory requirements and industry standards. This includes preparing and submitting regulatory documents, interacting with government agencies such as the Food and Drug Administration (FDA) Philippines, and ensuring that all products meet the necessary approval processes for marketing in the country.

Duties and Responsibilities:

Regulatory Submissions and Filings:

• Assist in the preparation and submission of regulatory documents, including applications for product registration, licenses, and other regulatory approvals required by the FDA Philippines and other relevant agencies.
• Prepare and review regulatory dossiers for product registrations, renewals, variations, and other regulatory filings.
• Monitor the progress of product submissions and track submission deadlines to ensure timely filings.

Regulatory Compliance and Guidance:

• Provide regulatory advice to internal teams (e.g., R&D, manufacturing, quality control) to ensure product development and manufacturing processes comply with local regulations.
• Ensure that the company's products, labeling, advertising, and promotional materials meet Philippine regulatory requirements.
• Monitor changes in regulatory laws and guidelines in the Philippines and update internal teams on new or revised requirements.

Communication with Regulatory Authorities:

• Act as a liaison between the company and local regulatory authorities, including the FDA Philippines, Department of Health (DOH), and other relevant government bodies.
• Assist in preparing responses to queries or requests from regulatory agencies and handle follow-up on submissions.
• Support the regulatory team during audits or inspections by regulatory authorities.

Post-Market Surveillance and Compliance:

• Assist in post-market surveillance activities, ensuring products remain compliant after launch in the market.
• Coordinate the preparation of periodic reports, including Adverse Event Reports (AERs), Periodic Safety Update Reports (PSURs), and other required documentation.
• Support activities related to product recalls, if necessary, and ensure compliance with the regulatory authorities' requirements for recall procedures.

Documentation and Record Keeping:

• Maintain accurate and organized records of regulatory submissions, correspondence, and approvals.
• Assist in ensuring that regulatory documents are updated and accessible for audits, inspections, and regulatory compliance reviews.
• Keep detailed records of the company's interactions with the FDA Philippines and other regulatory bodies.

Market Intelligence and Regulatory Research:

• Stay updated on local regulatory changes, trends, and industry news to ensure the company remains compliant with evolving regulations.
• Research and analyze local regulatory requirements for new products, product changes, or market expansions.

Cross-functional Collaboration:

• Work closely with internal departments such as legal, marketing, R&D, and manufacturing to ensure that products are developed, produced, and marketed in compliance with regulatory standards.
• Assist in the preparation of regulatory strategies for new products, ensuring adherence to local regulations from the early stages of development.

Job Type: Full-time

Benefits:

• Company Christmas gift
• Company events
• Employee discount
• Opportunities for promotion
• Paid training
• Promotion to permanent employee

Education:

• Bachelor's (Preferred)

Experience:

• Regulatory Pharmacist: 1 year (Preferred)

Language:

• English (Preferred)

Work Location: In person