Job Information
Abbott Regulatory Affairs Manager - Established Pharmaceuticals Division in Taguig City, Philippines
MAIN PURPOSE OF ROLE
SpecialistprofessionalindividualcontributorwithcomprehensiveknowledgeintheareaofRegulatoryAffairs.
Abilitytoexecutehighlycomplexorspecializedprojects.
Adaptsprecedentandmaymakesignificantdeparturesfromtraditionalapproachestodevelopsolutions.
MAIN RESPONSIBILITIES
AstheSpecialistintheRegulatoryAffairs Sub-Function,consideredashighlyexperiencedandknowledgeableresourcewithintheorganizationindirectingdevelopmentofproductregistrationsubmission,progressreports,supplements,amendments,orperiodicexperiencereports.
Interactswithregulatoryagencytoexpediteapprovalofpendingregistration.
Servesasregulatoryliaisonthroughoutproductlifecycle.
Participatesinsomeofthefollowing:productplandevelopmentandimplementation,regulatorystrategy,riskmanagement,chemistrymanufacturingcontrol(CMC).
Ensurestimelyapprovalofnewdrugs,biologicsormedicaldevicesandcontinuedapprovalofmarketedproducts.
Servesasregulatoryrepresentativetomarketing,researchteamsandregulatoryagencies.
Advisesdevelopmentand/ormarketingteamsonmanufacturingchanges,lineextensions,technicallabeling,appropriateregulationsandinterpretations.
QUALIFICATIONS
Education
- AssociatesDegree(± 13years)
Experience/Background
- Minimum 7 years
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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