Spec, RA, Post Approvals
Baxter International · Ahmedabad · onsite · Posted 63d ago
Not disclosedFresherfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- 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.
Sourced from foundit
Skills
R&DQa/Qccompliancemarketing
About Baxter International
Baxter International
Healthcare
5k+
employees
1931
95 years old
Kolkata, West Bengal
India
₹20.4L PA avg
Avg at Baxter International
About
Baxter hires a range of talented and driven individuals with diverse skill sets and backgrounds, from scientists and researchers to industry professionals in manufacturing, engineering and technology,
Industries
HealthcareMedical EquipmentPharma
Employee ratings
10 reviews
3.8/ 5
Culture
3.9
Career growth
2.1
Work-life
3.5
Employees rate it well for
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