Senior Specialist

RXinsider LTD.; India; On-site; INR 1,300,000 - 1,700,000; Full time

Job summary

Baxter in India is seeking a Regulatory Affairs professional to lead global regulatory strategies, obtain and maintain marketing authorizations, and communicate regulatory requirements to support product licensing.

Under limited supervision, you will develop plans, identify regulatory risks, prepare labeling and SOPs, and coordinate with project teams to ensure timely submissions.

Qualifications

• Knowledge of regulatory requirements for pharma/medical devices.
• Strong scientific understanding and data interpretation.
• Experience in managing multiple regulatory projects and deadlines.
• Ability to multitask and prioritize across portfolios.
• Excellent interpersonal and written/spoken communication skills.
• Negotiation and regulatory authority liaison experience.
• Proficiency with standard software (word processing, spreadsheets, databases).
• Ability to identify compliance risks and escalate appropriately.

Responsibilities

• Develop and execute regulatory project plans under limited supervision.
• Identify regulatory risks and communicate impact to teams.
• Maintain regulatory files in compliant format.
• Stay aware of regulatory requirements and applicable changes.
• Provide regulatory advice to project teams as needed.
• Respond to regulatory authorities within timelines.
• Prepare and submit regulatory documents per requirements.
• Update existing regulatory authorizations as needed.
• Coordinate labeling and standard operating procedures.
• Represent or lead Regulatory Affairs in small project teams.

Skills

Regulatory knowledge

Scientific knowledge

Project management

Multitasking

Communication

Negotiation

Technical systems

Risk identification

Education

Bachelor's degree in a scientific discipline

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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.