Overview:
We are seeking a proactive and detail-oriented Entry-Level Regulatory Affairs Coordinator to join our consultancy in Cambridge, MA. This role is an excellent opportunity for someone looking to begin their career in regulatory affairs, providing essential support to the regulatory team.
Responsibilities:
Assist in organizing and maintaining regulatory documentation and databases, ensuring accuracy and compliance with established standards.
Support the preparation and review of regulatory documents and submissions under the guidance of senior regulatory staff.
Aid in coordinating communication with regulatory agencies, assisting in drafting correspondence, meeting agendas, and documentation as needed.
Help maintain records for audits and inspections, ensuring documentation readiness and compliance.
Monitor regulatory updates and changes, assisting in collating information and distributing relevant updates to the regulatory team.
Assist in tracking timelines and milestones for regulatory submissions and activities to support project goals.
Requirements:
Bachelor’s degree in a scientific discipline, life sciences, or related field (preferred).
No prior professional experience required; internships or coursework in regulatory affairs or life sciences are advantageous.
Basic understanding of regulatory requirements and guidelines (FDA, EMA, etc.) is a plus.
Strong organizational skills with a keen attention to detail.
Proficient in Microsoft Office Suite and ability to learn new software or databases quickly.
Excellent communication and teamwork skills.
Benefits:
Competitive entry-level compensation package.
Opportunity to gain hands-on experience in regulatory affairs in a consultancy setting.
On-site work location in Cambridge, MA.
Collaborative and supportive work environment.
Potential for growth and development within the organization.