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Regulatory Affairs Assistant

Job Category:

Healthcare / Science

Job Level:

Professional

Open Date:

05-Jul-2019

Location:

CITY OF PASIG

Close date:

08-Aug-2019

Client Industry:

PHARMACEUTICAL

Job Description and Qualification:

Job Qualification:

Candidate must possess at least a Bachelor's/College Degree in Pharmacy

Good Communication Skills

Ability to multi task, set priorities and manage time effectively

Candidate must be a registered pharmacist

Candidate must have a regulatory affairs background

Amendable for Shifting Schedules

Can Start ASAP

Willing to work in Ortigas Area


Job description:

The Regulatory Affairs Assistant is responsible in providing and assisting regulatory work and implementation of approvals of new products, maintaining compliance for marketed products, and providing regulatory support for new business opportunities.  The person is also responsible for the alignment of goals and objectives of global regulatory partners and establishing relationship with drug agency officials. The person is also responsible for the following Functions, Duties and Tasks:

  • Develop and prepare regulatory plan and ensure alignment with the affiliate business plan, area and product team strategies
  • preparation of application and response and make final review prior to formal submission to ensure quality, timing and meets local or corporate requirements
  • Work on DRA approval of all regulatory submissions
  • Ensure that all marketed products are in compliance with Good Regulatory Practices that meet local and corporate regulatory requirements
  • Ensure the completion of global and IC regulatory core curriculum and Good Regulatory Practices training
  • Build and establish relationship with key regulatory officials
  • Keep updated with current local regulations and regulatory affairs organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or affected parties
  • Develop and implement the external regulatory influence strategy.


Salary:

25,000.00