Job Description

Vacancy for Regulatory Associate at Indegene 2023. Candidate will need to plan, prepare, and submit high-quality regulatory dossiers to the Health Authorities of ASEAN markets – Australia, Cambodia, Hong Kong, Korea, Malaysia, Macao, Indonesia, Pakistan, Philippines, Singapore, Taiwan Thailand, Vietnam

Organization	Indegene
Post Name	Regulatory Associate
Job Location	Bangalore
Official Website	https://www.indegene.com/

Job Title/Position:

Regulatory Associate

Job Overview:

Job vacancy for Pharmacy

Job Location:

Bangalore

What are the Key Responsibilities?

Basic medical/pharma/scientific knowledge that can be applied in developing regulatory submission documents
Thorough knowledge of major HA global/regional/national country requirements/regulatory affairs procedures for initial submission, licensing, post approval submission management
Markets Handled: Australia, Cambodia, Hong Kong, Korea, Malaysia, Macao, Indonesia, Pakistan, Philippines, Singapore, Taiwan Thailand, Vietnam
Prepare and compile global regulatory dossiers in ACTD, eCTD and non eCTD format in accordance with ASEAN HA legislations and client specific requirements
Prioritise, plan, and monitor submissions for allocated products while documenting and informing involved parties of progress
Able to support and prepare Module 1 documents – submission form, cover letter, notification forms, comparison tables for regulatory submission
Assist in the preparation and submission of post-approval regulatory filings, variations, and renewal applications
Hands-on experience on regulatory document management systems and publishing tools
Able to create submission packages in line with regulatory strategy for pharmaceutical drugs, vaccines, generics, GMO’s, and biological products
Coordinate with cross-functional teams, including R&D, quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation
Regular tracking and maintaining the submission trackers
Stay updated with evolving regulatory requirements and industry trends and able to extract regulatory intelligence information (requirements for initial filing, drug/device/cosmetic/food registration etc.)
Participate in trainings and learn through hands-on experience on the job
Exhibit flexibility in moving across new projects and preparing multiple document types
Continuously enhance and maintain knowledge of various regulatory guidelines for different deliverables by doing various assignments
Volunteer in training programs to develop skills in areas relevant to the job in addition to the areas of interest

What are the Educational Qualification(s) for Regulatory Associate?

BPharm / MPharm/ Pharm D/ MSc

What is the Experience Required for this Job?

Required 2-4 years of experience in ASEAN markets.
Experience with global regulatory submission formats and ACTD/eCTD/ /NeeS/Paper dossiers format, including familiarity with submission publishing activities is required.

Related:

Detailed notice

https://careers.indegene.com/job/Bangalore-Regulatory-Associate-KA/20339744/

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