Associate Director @ Acura Solutions

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Associate Director

Acura Solutions
9 to 12 Yrs
Multi-City, India
4 years ago
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Job Description

Required knowledge, skills and abilities

Experience in driving Labelling Centre of Excellence vision and goals
Subject Matter Expert in pharmaceutical product labelling
Ability to provide strategic input to develop technology-enabled labelling services
Ability to provide strategic input to expand GRA labelling capabilities
Ability to provide strategic input based on planned and draft regulatory changes related to labelling (e.g. move to electronic Product Information)

Proven expertise in global labelling processes (including European Centralised, Mutual Recognition and Decentralised Procedure requirements for MAAs and variations) from initial change request through to implementation in the local market

Proven expertise in global labelling outputs, including Company Core Data Sheets (CCDS),
justification document, Reference Safety Information (RSI), basis and reference labels, core and local labelling including artwork

Proven expertise in CTD Module 1 Product Information and Module 2.5 (clinical overviewaddendum)

Proven expertise and experience in chairing Global Labelling Committee meetings for the review of CCDS and RSI

Good understanding of US labelling requirements, including SPL format
Good understanding of process for preparation of initial CCDS from clinical trial data and Target
product profile
Good understanding of pharmacovigilance activities related to Reference Safety Information for
marketed products
Proven expertise for regulatory review of promotional material (AdPromo) for local market
Prepare and provide labelling training, including AdPromo for both regulatory and medical reviewers

Preferably, experience in labelling technology systems e.g. ZINC for AdPromo review and approval, RIM system with Labelling Module

Line Manager for supporting global labelling strategic projects

Regards

Employement Category:

Employement Type: Full time
Industry: Medical / Healthcare
Role Category: IT Operations / EDP / MIS
Functional Area: Not Applicable
Role/Responsibilies: Associate Director

Contact Details:

Company: Acura Solutions
Location(s): Multi-City, India

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Keyskills: labels regulatory affairs line management

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Your name (*)

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Preferred City (* max. 2 w/comma)

Designation / Expected Role

Current / Recent Company (*)

Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

Add social media [ + ]

Create password

I agree with website service terms and conditions

Acura Solutions

Leading recruitment firmÂ with forte in BFSI sector. Acura solutions is a recruitment firm that specialises in banking recruitments. We love recuitments, and we are looking for banking PROFFESIONALS and EX-PROFFESIONALS with a PASSION to be successful in life by working full time with us. We wil...

Associate Director @ Acura Solutions

Home > IT Operations / EDP / MIS