Regulatory Affairs Senior Specialist

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

On-site - Taguig 5-10 Yrs Exp Bachelor Full-time

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Job Description

The Regulatory Affairs Senior Specialist supports the preparation and submission of regulatory documents, ensuring compliance with local and international pharmaceutical regulations. The role involves liaising with regulatory authorities to ensure timely approvals and maintaining regulatory compliance for pharmaceutical products.

Required Technical Skills:

• Licensed Pharmacist
• At least 7 years of experience in Regulatory Affairs including liaising with regulatory authorities.
• With understanding of regulatory requirements and guidelines (e.g., FDA, ASEAN, WHO, ICH).

Key Responsibilities:

Regulatory Submissions:

• Prepare, compile, and submit product registration dossiers, renewals, and variations in accordance with regulatory requirements.
• Liaise with regulatory authorities to follow up on submissions and address queries or deficiencies promptly.

Documentation Management:

• Organize and maintain regulatory files, records, and databases to ensure accurate tracking of submissions and approvals.
• Ensure all regulatory documentation is complete, accurate, and compliant with relevant guidelines.

Compliance Monitoring:

• Monitor updates in regulatory requirements and guidelines and assist in implementing necessary changes.
• Review labeling, packaging, and promotional materials to ensure regulatory compliance.

Cross-Functional Support:

• Collaborate with internal teams (e.g., Quality, Manufacturing, Marketing) to gather required documents and data for regulatory purposes.
• Provide regulatory support during product development and lifecycle management.

Communication with Authorities:

• Serve as a primary contact for regulatory authorities, ensuring effective communication and addressing regulatory concerns.
• Maintain strong working relationships with key stakeholders in regulatory agencies

Preview

Active within three days

Working Location

Unit 1001-1002, 10th Floor Trade and Financial Tower 7th Ave. cor. 32nd St., Bonifacio Global City, Taguig, NCR, PH

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