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Manager / Senior Manager - RA (EU& US Markets)

Manager / Senior Manager - RA (EU& US Markets)

Panacea Biotec

10 - 15 years

20 - 25 Lacs

Chandigarh Dera Bassi

Posted:2 hours ago| Platform:

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Skills Required

Europe Market Dossier Preparation ICH-GCP Guidelines US Market Ectd

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities Review and submission of ANDA 505 (J) application for US market. CMC writing, Query management, Labeling, RIMS, Drug Listing, Pre-and Post-Approval Changes (Life cycle management) and Publishing as per USFDA/EU. Proficient in cross functional team communication with internal and external stakeholders. Functional experience in end to end project management and handling team Preferred candidate profile Candidate must have experience in Regulatory filling and product life cycle management for in EU & US markets Perks and benefits 20lpa to 30 lpa

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Panacea Biotec

www.panaceabiotec.com

Pharmaceutical Manufacturing

New Delhi Delhi

1001-5000 Employees

23 Jobs

Key People

Dr. Sudhanshu Pandey

Managing Director
Rajesh K. Sharma

CEO
Dr. Anil P. Mankotia

Chief Scientific Officer

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Manager / Senior Manager - RA (EU& US Markets)