Assistant Regulatory Pharmacist

POSITION OBJECTIVE:

The pharmacist assistant regulatory primary job is to assist and helps the regulatory pharmacist in all regulatory matters and concerns related to FDA, IPO, and other areas where pharmaceutical expertise is relevant.

To ensure the appropriate licensing, marketing, and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products in local government agencies as specified below.

May be required to do another task that may be assigned from time to time.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

FOOD AND DRUG ADMINISTRATION

• Ensuring that a company's products comply with the regulations of the FDA standards;
• Preparing submissions of dossiers to strict deadlines like Renewal Registration, Amendment / Variations, re-issuance of CPR, Query Letters, and other concerns relative to FDA approval.
• Monitoring and setting timelines for license or product variations...