Senior Specialist, Regulatory Affairs
Baxter International
Budapest, Hungary
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 review AdProm materials for compliance with local regulations
- Prepare SOPs to reflect specific local requirements
- 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 escalate 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
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