Drive local regulatory submissions as a skilled Associate in Regulatory Affairs. Collaborate cross-functionally to ensure compliance and timely delivery of documentation, supporting both local and corporate requirements.
In this role, you will coordinate and execute regulatory documentation in adherence to standards and guidelines. Engaging with International Regulatory Leads and team members, you’ll ensure all submissions meet regulations. Key responsibilities focus on process improvement and effective communication with local health authorities.
Key Responsibilities:
• Execute preparation and electronic archiving for submissions
• Partner with teams to coordinate regulatory documents
• Ensure timely submission compliance with regulations
• Participate in local regulatory process improvements
• Engage with health authorities for routine communications
Requirements:
• Bachelor’s degree in Science required
• Experience in regulatory affairs is mandatory
• 1+ year of relevant regulatory experience preferred
• Knowledge of drug development and regulations
• Effective communication and cross-functional collaboration skills
Utilize your regulatory expertise to support submission processes and ensure compliance in a fulfilling role within a team-oriented environment.
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