Assoc, RAReq # JR - 053059 Location Ahmedabad, Gujarat, India Job Category Regulatory Affairs Date posted 11/03/2021
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Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
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Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Job Description - Associate
i. Ensure the on-time filing of high-quality regulatory submissions, and to assist in the preparation, maintenance, and control of regulatory Dossiers
ii. Interact with all levels in the organization, and across several functions particularly Compliance, Marketing, R&D, engineering, manufacturing and QA/QC.
iii. Participate in discussions to provide strategic regulatory guidance to team members in India and other Region operations.
iv. Interact with regulatory agency on regulatory submissions and follow ups of drug products.
v. Oversee the preparation and filing of high-quality submissions to regulatory authorities.
vi. Ensure that all applications are filed in accordance with regulations and requirements.
vii. Provide regulatory guidance to staff and inter-disciplinary project teams.
viii. Be a proactive member of the Regulatory team to ensure Baxter’s continuing compliance
with regulatory authorities.
ix. Continue to develop quality standards and procedures for RA.
x. Facilitate product development/Launch activities for respective Markets.
Education: M. Pharm.
Experience: Should have exposure for Injectable formulations in LATAM Market
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