Senior Specialist

Baxter; Ahmedabad District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Baxter is seeking a Regulatory Affairs professional in India to implement global regulatory strategies and obtain/maintain marketing authorizations for products, while communicating general regulatory requirements in support of licensing.

The role includes developing project plans, identifying regulatory risks, maintaining files, and coordinating with project teams to ensure timely submissions and compliance across portfolios.

Qualifications

• Knowledge of regulations and regulatory pathways.
• Solid scientific background relevant to medical devices or pharmaceuticals.
• Experience in project management and coordinating cross-functional teams.
• Ability to multitask, manage deadlines and adapt to changing priorities.
• Strong written and oral communication, negotiation, and regulatory liaison skills.
• Familiarity with basic technical tools (word processing, spreadsheets, databases).
• Ability to identify compliance risks and escalate appropriately.

Responsibilities

• Develop and execute regulatory project plans under limited supervision.
• Identify and elevate regulatory risks and maintain regulatory files.
• Communicate regulatory requirements and provide advice to project teams.
• Respond to questions from authorities within timelines and prepare regulatory submissions.
• Maintain and update regulatory authorizations for products/projects.
• Review labeling, SOPs, and related regulatory documents.

Skills

Regulatory knowledge

Scientific knowledge

Project management

Multi-project management

Prioritization

Interpersonal & communication

Negotiation skills

Technical systems

Regulatory risk identification

Education

Bachelor’s degree in a scientific discipline

Job description

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 or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.