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Job id : 161523

Spec, RA (Open)

Spec, RA (Open)

  Ahmedabad
   Baxter        Ahmedabad
  6 hours ago   

JOB ID:161523

Job details

Job Type

  Full Time

Functional Area

Accounting / Finance / Tax / CS / Audit

Industry

Medical/Healthcare/Hospital

Education

Not Specified

Experience Required

  3 - 6 Yrs

Key Skills Required

  high-quality regulatory submissions

Other Skills Required

 

Job Description

Ahmedabad – GPRD

· Ensure the on-time filing of high-quality regulatory submissions, and to assist in the preparation, maintenance, and control of regulatory Dossiers.

· Interact with all levels in the organization, and across several functions particularly Compliance, Marketing, R&D, engineering, manufacturing and QA/QC.

· Participate in discussions to provide strategic regulatory guidance to team members in India and other Region operations.

· Interact with regulatory agency on regulatory submissions and follow ups of drug products.

· Oversee the preparation and filing of high-quality submissions to regulatory authorities.

· Ensure that all applications are filed in accordance with regulations and requirements.

· Provide regulatory guidance to staff and inter-disciplinary project teams.

· Be a proactive member of the Regulatory team to ensure Baxter’s continuing compliance with regulatory authorities.

· Continue to develop quality standards and procedures for RA.

· Facilitate prod

...  See More

Ahmedabad – GPRD

· Ensure the on-time filing of high-quality regulatory submissions, and to assist in the preparation, maintenance, and control of regulatory Dossiers.

· Interact with all levels in the organization, and across several functions particularly Compliance, Marketing, R&D, engineering, manufacturing and QA/QC.

· Participate in discussions to provide strategic regulatory guidance to team members in India and other Region operations.

· Interact with regulatory agency on regulatory submissions and follow ups of drug products.

· Oversee the preparation and filing of high-quality submissions to regulatory authorities.

· Ensure that all applications are filed in accordance with regulations and requirements.

· Provide regulatory guidance to staff and inter-disciplinary project teams.

· Be a proactive member of the Regulatory team to ensure Baxter’s continuing compliance with regulatory authorities.

· Continue to develop quality standards and procedures for RA.

· Facilitate product development/Launch activities for respective Markets. See Less

About Company

This is where you can make an impact.

As an innovative, global healthcare leader, Baxter offers advanced products, technologies and therapies that support people to lead healthier, longer lives.

When you join Baxter, you’ll find purpose and pride as we meet the challenges faced by the patients, clinicians, and customers we serve in this rapidly evolving healthcare landscape.

Together, we create a place where we are resilient, focused on our future, and connected by our mission to save and sustain lives.

This is where you can do your best work, where your purpose accelerates our mission.