Regulatory Affairs Specialist

2 days ago


Metro Manila, Philippines BASEMED KARE INC Full time

Regulatory Submission:

Prepare and submit regulatory documents, including pre-market applications, annual reports, and product labeling.Ensure timely and accurate submissions to regulatory agencies.

Compliance Monitoring:

Monitor changes in regulations and assess their impact on the organization.Maintain knowledge of industry standards and best practices.

Cross-Functional Collaboration:

Work closely with R&D, quality assurance, and manufacturing teams to ensure regulatory compliance in product development and manufacturing processes.Provide regulatory guidance during product development to ensure timely approvals.

Risk Assessment:

Evaluate potential risks associated with regulatory compliance and provide recommendations for mitigation.Conduct audits and inspections as needed.

Communication:

Act as the primary point of contact for regulatory inquiries from internal stakeholders and external agencies.Prepare and deliver training on regulatory requirements and compliance processes.

Documentation Management:

Maintain organized records of all regulatory submissions and correspondence.Ensure that documentation is up-to-date and accessible for audits and inspections.

 

Qualifications:

Candidate must possess at least a Bachelor's/College Degree of Pharmacy (any related field)At least 2-3 year(s) of working experience in Regulatory dealing with government agencies like FDA, PNRI and DTI-Bureau of Product Standards.Very good record/ document keeper, updated on government agencies regulations, proactive, very good communication skills and inter-personal skills.Ensures that Basemed is compliant on all permits and licenses and accreditations.Must be a Licensed PharmacistFull-Time position(s) availableSalary range at 28k – 30kWill act as Qualified person

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