Work as Regulatory Compliance Information Specialist at Merck Limited

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Merck Limited (formerly E. Merck Limited) was set up in India as the first Merck subsidiary in Asia in 1967.  The Company operates both its Pharmaceuticals and Chemicals businesses in the country. Merck was also the first Merck Group Company to go public in the year 1981.  The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd. and National Stock Exchange of India Ltd.  Merck Specialities Pvt. Ltd., the wholly owned Indian subsidiary of Merck KGaA, was incorporated in 2005.

Post : Regulatory Compliance Information Specialist

Job Description
• Contribution as Subject Matter Expert with dedicated business process know how for Regulatory Information Management and Standards to our cross-functional projects and strategic initiatives like IDMP as well as the implementation of Veeva Vault
• Ensure data governance rules (master/meta data dictionaries, processes and data flow across multiple applications) are implemented and followed to achieve as well as maintain global data consistency of IDMP related applications and systems (RIMS, xEVMPD, IDMP):
* Define data quality measures for data entry and data maintenance processes and manage evaluation of data quality
* Define and implement reports and controls to verify and monitor regulatory data quality
* Conduct and support data quality activities like data migration, data verification, data completion, or data clean-up/correction incl. xEVMPD/IDMP maintenance
* Monitor and report on compliance with defined data quality standards
• Ensure that the future – merged of Regulatory Data (e.g. xEVMPD, IDMP, ePI) and dossier submission processes (eCTD, eAF, CESSP, EU-CTR) are properly taken into account in organization processes.
• Consolidate corrective action plans to improve regulatory data quality
• Partner with GRA and other functions, departments and divisions for regulatory data management related topics
• Provide support, documentation, training and end user communication for regulatory data management related topics
• Provide data management methodology knowhow to support the processes in GRA OPS
• Support user community to analyze system data and provide recommendations for these analysis
• Export and extract system data and provide ad hoc reports as required

Candidate Profile
• At least 5 years of experience from a pharmaceutical industry or service provider with strong business focus
• At least 3 years in Regulatory Affairs with a knack for data management
• Excellent data management experience including data governance and master data management
• In-depth expertise on both regulatory processes for submission of data and documents for medicinal products (e.g. xEVMPD, IDMP, IND, CTA, MAA, lifecycle management) and utilisation of regulatory systems (RIMS, DMS, SAP)
• Experience in Veeva Vault is a plus
• Fluent English
• Work independently, self-motivated
• Goal-oriented, pragmatic, meticulous working style, high attitude to quality
• Agile mindset and change oriented
• Strong service mentality
• Excellent communication skills

Additional Information
Experience : 4-9 years
Location : Bangalore
Qualification : Professional
Industry Type : Pharma/ Healthcare/ Clinical research
Job Requisition ID : 198311
End Date : 20th October, 2019


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