Senior Specialist

Baxter International Inc.; Ahmedabad District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Baxter International Inc. is seeking a Regulatory Affairs professional in India to lead regulatory strategies and ensure timely approvals for product portfolios. You will support global and local regulatory activities, interact with authorities, and coordinate labeling/SOP reviews.

The role requires a scientific degree and extensive regulatory experience, with strong project management and cross-functional collaboration skills for successful outcomes.

Qualifications

• Knowledge of regulations
• Scientific knowledge
• Project management skills
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Negotiation skills
• Technical system skills (word processing, spreadsheets, databases)
• Ability to identify compliance risks and escalate as needed

Responsibilities

• Develop and execute regulatory project plans
• Identify regulatory risk areas and elevate them
• Maintain regulatory files per requirements
• Stay aware of regulatory requirements and identify relevant ones
• Provide regulatory advice to project teams as required
• Respond to regulatory authorities within timelines
• Compile and submit regulatory documents per requirements
• Maintain and update existing regulatory authorizations
• Support regulatory activities for product portfolio
• Prepare, review, and approve labeling and SOPs
• Lead Regulatory Affairs in small project teams

Skills

Regulatory knowledge

Project management

Multitasking & prioritization

Interpersonal & communication

Negotiation

Regulatory documentation

Regulatory strategy

Team collaboration

Education

Bachelor's degree in science

Job description

This is whereyour work makes a difference.

At Baxter, we believe every person - regardless of who they are or where they are from - deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job - you will find purpose and pride.

Summary

Under limited supervision responsible for the implementation of global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter's products. Support regulatory activities relating to specific portfolio of global products/projects.

Essential Duties and Responsibilities

• With direction, develop and execute regulatory project plans
• Identify and elevate key areas of regulatory risk
• Maintain regulatory files in a format consistent with requirements
• Maintain awareness of regulatory requirements; identify relevant requirements
• Participate as an active team member and provide regulatory advice to project teams as required
• Respond to questions from regulatory authorities within strict timelines
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Maintain and update existing regulatory authorizations
• Support regulatory activities relating to specific portfolio of products/projects
• Prepare, review, and approve labeling and SOP's
• Represent or lead Regulatory Affairs in small project teams

Qualifications

• Knowledge of regulations
• Scientific knowledge
• Project management skills
• Manage multiple projects and deadlines
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Negotiation skills
• Technical system skills (e.g., word processing, spreadsheets, databases, online research)
• Ability to identify compliance risks and elevate when necessary

Education and/or Experience

Bachelor's degree or country equivalent in a scientific discipline. Minimum of 2 years regulatory experience along with 8-10 years total experience within a pharmaceutical and/or medical device company, CRO, or similar organization.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.