Sr. Regulatory Specialist

Saviour MeDevices, Inc.; Philippines; On-site; PHP 420,000 - 720,000; Full time

Job summary

Saviour MeDevices, Inc. is seeking a Regulatory Compliance professional to manage licensing and product registrations with the FDA.

The role requires coordinating regulatory submissions, maintaining complete records, and ensuring ongoing compliance with evolving regulations. The ideal candidate has a Pharmacy degree and licensed pharmacist status, with strong English and Filipino communication, attention to detail, and the ability to work onsite from Boni Avenue, Mandaluyong City, Monday to

Qualifications

• Bachelor's degree in Pharmacy and must be a Licensed Pharmacist.
• Experience or familiarity with regulatory affairs and willingness to learn.
• Knowledge of FDA regulations, FDA Portal, and PhilGEPS.

Responsibilities

• Manage licensing and registration of all registrable products with the FDA.
• Prepare, review, and submit regulatory documentation for product registration and approvals.
• Monitor regulatory updates to ensure compliance with national standards.
• Maintain secure records of regulatory documents and licenses.

Skills

Regulatory awareness

English/Filipino communication

Attention to detail

Analytical thinking

Reporting skills

Regulatory submissions

Education

Bachelor's Degree in Pharmacy

Licensed Pharmacist

Tools

FDA Portal

PhilGEPS

Job description

Employment Type: Full-Time

Work Setup: 100% Onsite Work

Work Location: Boni Avenue, Mandaluyong City

Qualifications:

• Bachelor's Degree in Pharmacy and must be a Licensed Pharmacist.
• With experience or background in Regulatory Affairs; fresh graduates are welcome to apply, provided they have relevant knowledge or familiarity with regulatory processes and are willing to learn and be trained.
• Knowledgeable or familiar with FDA regulations, FDA Portal, and PhilGEPS.
• Familiarity with FDA rules, regulations, and compliance requirements.
• Excellent oral and written communication skills in English and Filipino, with good interpersonal skills.
• Strong critical-thinking, decision-making, presentation, and reporting skills.
• Detail-oriented, organized, and able to manage tasks accurately.
• Able to work with minimal supervision and perform effectively under pressure.
• Willing to work 100% onsite, Monday to Friday.

Brief Job Description:

Regulatory Compliance and Product Registration

• Manage the licensing and registration of all registrable products distributed by the company with the FDA.
• Prepare, review, and submit regulatory documentation required for product registration, renewal, amendments, and other regulatory approvals.
• Monitor regulatory updates, policies, and guidelines to ensure continued compliance with national regulatory standards.
• Ensure all regulatory submissions meet completeness, accuracy, and timeliness requirements.

Documentation and Records Management

• Maintain secure, organized, and confidential records of all regulatory documents, licenses, product registrations, and company compliance records.
• Prepare regulatory reports and maintatin accurate records of all registrable disposable products distributed or sold by the company.
• Track validity periods of regulatory permits and licenses to ensure timely renewal and uninterrupted compliance.

Product Evaluation, Safety, and Compliance Monitoring

• Facilitate product evaluations related to quality concerns, customer complaints, and product integrity issues.
• Coordinate product recall processes when required, ensuring compliance with regulatory reporting and documentation procedures.
• Support internal investigations related to product quality, regulatory concerns, and corrective actions.

Regulatory Representation and External Coordination

• Represent the company in regulatory engagements, submissions, and official communications with regulatory authorities.
• Liaise with government agencies and regulatory bodies regarding compliance requirements, product registrations, and regulatory inquiries.
• Respond promptly to regulatory communications, directives, or compliance notices from the FDA and other relevant authorities.

Coordination with Internal and External Stakeholders

• Coordinate with product principals and manufacturers to obtain complete documentation required for regulatory submissions and bidding requirements.
• Provide regulatory guidance and support to internal departments regarding compliance matters and documentation requirements.
• Assist Sales and Marketing teams in preparing regulatory documents required for bidding and procurement submissions.
• Ensure full compliance with the regulatory and licensing requirements specified by procuring entities during bidding processes.
• Perform other regulatory, compliance, documentation-related duties as assigned by the immediate superior to support organizational objectives and operational requirements.