Baxter International is a global leader in healthcare, driven by a mission to save and sustain lives. For over 85 years, Baxter’s innovative products have empowered healthcare professionals worldwide to deliver personalized care across hospitals, clinics, and homes. With a robust presence in medical devices and therapies, Baxter continuously pushes the boundaries of healthcare innovation. Joining Baxter means being part of a team dedicated to improving outcomes for millions of patients, fostering a collaborative environment, and promoting personal growth.
Responsibilities in the Job
As an Associate, Global Regulatory Affairs, based in Whitefield, Bengaluru, you will play a critical role in regulatory operations. Key responsibilities include:
- Collaborating with global and regional regulatory teams to align activities with business objectives.
- Supporting regulatory submissions and managing product registration processes.
- Handling product life cycle management activities, including post-market regulatory updates.
- Leveraging Trackwise8 for change control processes and RIMS-Veeva Vault for regulatory submissions.
- Tracking and monitoring the status of regulatory filings to ensure timely submissions.
- Maintaining accurate databases, systems, and regulatory trackers.
- Working closely with cross-functional teams such as R&D, quality assurance, and manufacturing to ensure smooth regulatory processes.
Qualifications
The ideal candidate for this role should possess the following qualifications:
- Educational Background: M.Pharm in Regulatory Affairs from a reputed institution.
- Experience: 0-2 years of experience in regulatory affairs or a related field.
- Strong knowledge of ICH guidelines and global health authority regulations.
- Experience with regulatory publishing tools and systems is preferred.
Skills Required
To succeed in this role, the candidate must demonstrate the following skills:
- Analytical Thinking: Ability to analyze regulatory challenges and find solutions.
- Organizational Skills: Managing multiple tasks effectively in a fast-paced environment.
- Communication Skills: Strong verbal and written communication for collaboration with global teams.
- Technical Proficiency: Expertise in Microsoft Excel, Word, and regulatory databases.
- Teamwork: Must be adaptable to work independently and collaboratively.
