Regulatory Affairs Associate Job at Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.

Post : Assoc, RA

Job Description
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.

Candidate Profile
• M.Pharm
• Should have exposure for Injectable formulations in LATAM Market

Additional Information
Qualification : M.Pharm
Location : Ahmedabad, Gujarat
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 30th November, 2021