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Regulatory Affairs Associate

2 months ago

Metro Manila, Philippines Ajanta Pharma Philippines Inc Full time

Job Title : Regulatory Affairs Associate

Reports to: Regulatory Affairs Manager

Ajanta Pharma Philippines,Inc.

Regulatory Affairs Associate 

Job Description

 

Responsibilities

ensure that a company's products comply with the regulations of Philippines Law including the FDA Philippines regulationskeep up to date with national and  Southeast Asian legislation, guidelines and practicescollect, collate and evaluate scientific data from a range of sources including post marketing surveillance and scientific journalsdevelop and write clear arguments and explanations for new product licenses and license renewals with the overview of the Regulatory Managerprepare submissions of license variations and renewals based on expiration if CPAs and compliance to strict deadlinesmonitor and set timelines for drug license variations and renewal approvalswrite clear, accessible product labels, patient information leaflets and product insertsdevelop phase 4 monitoring and interpret trial dataadvise scientists from research and development (India HQ) on regulatory requirementsprovide strategic advice to senior management throughout the development  and registration of a new productmanage regulatory inspections in either head office or warehousereview company practices and provide advice on changes to systemsliaise with, and make presentations to, regulatory authoritiesnegotiate with regulatory authorities for marketing authorizationTake part in the development of marketing concepts and approve packaging and advertising before a product's release in conjunction with product management .

Qualifications and Skills

Graduate of Pharmacy or Industrial PharmacyUpdated Valid PRC Pharmacy LicenseExperience in liaising with FDA Philippines desired     understanding of both legal and scientific matters pertaining to pharmaceuticalsthe ability to grasp new concepts quickly and to assimilate and evaluate scientific data from scientific literatureanalytical and problem-solving skillswritten and oral communication skillsattention to detailstrong negotiation skillsthe ability to work under pressure and to strict deadlinesthe confidence to report to higher managementteam working skills project-management skillsIntegrity and a professional approach to work.