At Baxter, we are deeply connected by our mission to save and sustain lives. For over 85 years, Baxter has been a global leader in medical innovations, providing essential products and therapies found in hospitals, clinics, and homes worldwide.
Our work impacts millions of patients, and we foster a culture where employees feel purpose-driven, happy, and successful. Join us in making a difference at the intersection of healthcare and innovation.
Job Description
Key Responsibilities:
- Ensure on-time filing of high-quality regulatory submissions for drug products.
- Assist in the preparation, maintenance, and control of regulatory dossiers.
- Collaborate with Compliance, Marketing, R&D, Engineering, Manufacturing, and QA/QC teams.
- Provide strategic regulatory guidance to teams in India and other regions.
- Interact with regulatory agencies for submissions and follow-ups.
- Oversee the preparation and filing of submissions to regulatory authorities.
- Ensure compliance with regulatory requirements and guidelines.
- Support product development and launch activities for respective markets.
- Continuously improve quality standards and procedures in Regulatory Affairs.
Qualifications & Skills:
- Strong knowledge of regulatory submissions and compliance.
- Experience in pharmaceutical or medical device regulatory affairs.
- Ability to work with cross-functional teams and regulatory agencies.
- Excellent communication and project management skills.
- Proactive mindset with a problem-solving approach.
Why Join Baxter?
- Impactful Work: Contribute to life-saving medical innovations.
- Global Presence: Work with teams across the world.
- Career Growth: Opportunities for professional development.
- Inclusive Culture: Commitment to diversity and reasonable accommodations for employees with disabilities.
