Careers

Executive - Regulatory Operations
Ref: Exe - Reg Ops

Location
Mumbai
Business Area/Department
Regulatory
Contract Type
Permanent

KEY RESPONSIBILITIES:

 

Providing eCTD and NeeS Publishing support for Concordia’s global product portfolio, ensuring that electronic submissions meet the required quality standards and internal/external deadlines.

 

Assistance in the development and implementation of new Regulatory processes and the continuous improvement thereof. 

 

Work closely across the company to implement, maintain and ensure compliance of Concordia’s Electronic Document Management System and Publishing system.

 

 

KEY ACCOUNTABILITIES:

 

•          Under guidance of the Senior Executive, provide management of submission compilation in line with eCTD or NeeS requirements (US, Europe, UK, AfME) for new and established products.

•          Creating PDF bookmarks and hyperlinks to ensure that submission review timelines are optimised.

•          Responsible for tracking and communicating the progress of submissions to the wider Regulatory function.

•          Play a key supporting role in wider projects within Regulatory Affairs, such as the establishment of a new Regulatory Information Management system and IDMP

•          Support systems projects by participating in (for example) vendor selections, systems evaluation, validation and implementation projects.

•          Participate in the migration of data between systems, as and when required.

•          Provide support to Regulatory Affairs colleagues in the management of documents and dossiers in our Document Management and Publishing systems.

•          Provide support and training to new systems users, by adopting a “Superuser” role for Concordia’s regulatory systems.

•          Support with the maintenance and development of Concordia policies and procedures for the management of publishing activities and supporting regulatory systems.

Job Description Download
Executive_Regulatory_Operations.docx

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