Sr. Regulatory Specialist

Saviour MeDevices, Inc.; Mandaluyong; On-site; PHP 391,000 - 614,000; Full time

Job summary

Saviour MeDevices, Inc. is seeking a Regulatory Compliance and Product Registration professional in Metro Manila. The role oversees licensing, product registration with the FDA, and regulatory submissions with accuracy and timeliness.

Ideal candidates have a pharmacy degree and are licensed pharmacists with knowledge of FDA rules and PhilGEPS, plus strong English and Filipino communication and attention to detail.

Qualifications

• Must be a licensed pharmacist with a pharmacy degree.
• Experience or familiarity with regulatory affairs is preferred or willingness to learn.
• Knowledge of FDA regulations and Philippine regulatory processes.
• Excellent written and verbal communication in English and Filipino.

Responsibilities

• Manage licensing and registration of registrable products with the FDA.
• Prepare, review, and submit regulatory documents for registrations and renewals.
• Monitor regulatory updates to ensure ongoing compliance.
• Ensure submissions meet completeness and timeliness.

Skills

Communication skills

Regulatory thinking

Detail-oriented

Independent/low supervision

On-site work

Education

Bachelor's degree in Pharmacy

Licensed Pharmacist

Tools

FDA Portal

PhilGEPS

Job description

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.