REGULATORY AFFAIRS SPECIALIST
Bloomington, IN
Req ID 51452BR
Business Title
Regulatory Affairs Specialist
Business
Medical Products
Sub-Business
Regulatory Affairs
Country
US
State/Province
Indiana
Location of Position
Bloomington, IN
Shift_
1st
Job Description
1. Coordinate and write global regulatory applications.
2. Collaborate with global regulatory counterparts and PharmaPartners to develop global regulatory strategy.
3. Provide regulatory risk evaluation and mitigation recommendations to project teams.
4. Provide guidance and coaching for areas of responsibility to lower level team members.
5. Respond to regulatory authority deficiency questions with strict deadlines
6. Maintain regulatory files in a format consistent with requirements•
7. Develop and initiate complex regulatory project plans
8. Manage regulatory activities relating to specific portfolio of products/projects (product owner)
9. Maintain and update existing regulatory authorizations
10. Lead or represent Regulatory Affairs in cross-functional project teams
11. May review promotional material for compliance with local regulations
12. Evaluation potential new products into shared manufacturing areas for potential regulatory impact to current products
13. Present regulatory project updates and regulation or guidance changes to Global Regulatory Affairs.
14. Revise and/or create regulatory Standard Operating Procedures, as necessary.
Job Requirements
•Exercise independent judgment
•Scientific knowledge
•Written and Verbal communication skills
•Knowledge of regulations
•Strong Negotiation skills
•Technical system skills (e.g. word processing, spreadsheets, databases, online research)
•Manage multiple projects and deadlines
•Ability to identify compliance risks and escalate when necessary
• Bachelor's degree or country equivalent in pharmacy or related scientific discipline with a minimum of 5 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
