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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.
Job Responsibility
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
Requirements
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 escalate when necessary
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.