Regulatory Affairs Manager (Ethical Pharma)

A Regulatory Affairs Manager (Ethical Pharma) job for an ethical pharmaceutical company in the Philippines has become available.

About the Regulatory Affairs Manager (Ethical Pharma) Role:
The Regulatory Affairs Manager role is responsible for ensuring that the company complies with the local, state and federal regulatory agency and governing body regulations and laws.

Key Responsibilities:

Regulatory Affairs Related

Food and Drug Administration (FDA)

• Responsible for the application process for product registration
• Monitoring and updating CPR; file and system maintenance
• Monitoring reports containing records of products with Batch Notification and Lot Release Certificate
• Monitoring and updating CGMP; file and system maintenance
• Coordinating with Regulatory Officer of company’s distributor to update list of product source
• Responsible for the submission of written reports such as destruction reports, other reports that any government agency may require
• Acting as a business partner to the Business Development team in assessment of registration potential for new portfolio/products expansion. Supporting due diligence assessments

Philippine Drug Enforcement Agency

• Acting as an authorised representative of the company empowered to deal with Philippine Drug Enforcement Agency (PDEA) with regards to drugs that are classified as dangerous drugs
• Responsible for the submission of a computerised report of all dangerous drugs’ receipts, issuances on or before cut off dates established by the bureau
• Providing FDA a report on damaged dangerous stocks and submits the actual stocks to their office for scheduled destruction

Quality Assurance

• Responsible for PH Importer and Wholesaler Licence
• Update/maintain/approve the quality management system
• Carrying out management review, internal audits on the company's and QA-related vendors and attending to external QA audits

Pharmacovigilance

• Ensure compliance to local PV regulations
• Creating and maintenance of PV SOPs
• Attending to external audits from heath authority or partners and support other relevant PV audits
• Resolving CAPA related to findings from audits

To succeed in this Regulatory Affairs Manager (Ethical Pharma) role, you must have extensive experience in dealing with FDA and PDEA with a secondary tasks of QA and Pharmacovigilance.

Key Requirements:

• BS Pharmacy degree holder from a reputable college or university. Must be a licensed pharmacist
• Minimum of five years' exposure of the same capacity
• Must have adept knowledge of the company’s operations
• Must have basic understanding of ISO 9001:2015
• Must have good working knowledge of MS Office (especially on Word, Excel and PowerPoint)

This organisation is highly acclaimed in the ethical pharmaceutical company and has a regional presence in different territories.

If you have a background in this, this Regulatory Affairs Manager (Ethical Pharma) role is right for you.

Apply today or contact me to discuss this new opportunity.

Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.