Regulatory Affairs Assistant

Industry Category	Healthcare	Position	Pharmacy
Recruitment Department		Number Of Recruits	several
Work Location	Metro Manila (NCR) Makati	Nature Of Work	Full Time
Gender Requirements	Male	Marriage Requirement	No marital status restrictions
Education Level	Bachelor's Degree	Work Experience	No work experience restrictions
Age Requirement	Above 18 years old	Salary Package	Negotiable
Updated Date	2022-10-06	Valid Until	Long-term validity

Assists in preparing all the technical documents required for submission to FDA and other regulatory agencies such as License to Operate, Initial/Renewal/ Variation applications as Medical Device Distributor and Product registration of all IVD/Medical DeviceResponsible for ensuring that all product registrations, licenses, and certificates are valid and submitted to FDA and other regulatory agencies for renewal prior to their expiration dateUpdate and monitor the registration status and validity date of all regulatory certificates and licensesEstablish and maintain a document filing system to ensure easy access of documentationResponsible for the safety and confidentiality of all regulatory records and documents of the companyEnsure compliance with local regulations and corporate policies and proceduresAccomplish regulatory reports for submission to immediate superiorParticipate in inspections of company facilities by FDA and other applicable agenciesMaintains good relationship with regulatory authorities but not limited to DOH, FDA, CDRRHR, PDEA, DDB, DENR, NTC, and OMBPerforms other regulatory-assigned activities and role in support of business objectives.

Qualifications

 Experience in IVD/ Medical Device/ Pharmaceutical regulatory industryKnowledgeable in office software programs including Excel, Word, PowerPoint, Outlook, Adobe Reader/Nitro ProGood presentation and communication skills both in oral & writtenMust be a good team playerAbility to multitask, prioritize, detail-oriented, adaptable, ability to work independently or under minimum supervisionMust be of good moral character (with character reference from previous employer)Willing to do field work if necessary

Be part of Marsman Medical Family and enjoy the following benefits!

Performance-based Salary Increase/Incentive and other BonusesHMO, Group Life and Accident InsuranceLeaves (with additional leaves)Optical Benefits and Medicine AllowanceScholarship Program (Employee & Dependent)Loyalty AwardsRetirement and many more...

Working Schedule: Monday-Friday *800:170