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Miltenyi Biotec · 11 hours ago

Sr. Regulatory Affairs Specialist I *PC 828

Boston, MA

Full-time

Onsite

Mid, Senior Level

$120K/yr - $141K/yr

5+ years exp

Miltenyi Biotec is a company focused on revolutionizing biomedical research through innovative solutions in cell and gene therapies. They are seeking a Sr. Regulatory Affairs Specialist I to manage regulatory filings, ensure compliance with FDA and Canadian Health Authorities, and develop strategies for regulatory approvals.

BioinformaticsBiotechnologyHealth CareMedical

Responsibilities

Initiate and manage regulatory filings associated with company sponsored registration trials with minimal supervision

Independently manage timelines of assigned projects in accordance with established regulatory goals

Write, review, coordinate and compile submissions to US FDA and Canadian Health Authorities, while maintaining accuracy and consistency across jurisdictions with minimal assistance

Promote corporate awareness of CMC requirements, GMP requirements, and industry trends

Develop and recommend strategies to expedite Master File submissions and regulatory approvals

Review internal documentation including SOPs, material specifications and stability protocols

Maintain regulatory SOPs and creates new processes and policies as needed

Evaluate the regulatory impact of GMP compliance and validation issues

Independently review manufacturing changes for change control and associated regulatory risk assessments and communicates findings directly to other departments on behalf of Regulatory Affairs

Develop and contribute to RA process improvements to increase efficiency and accuracy of submissions to the FDA

Cross train staff and provides onboarding assistance for new hires as needed to maximize resources within the department

Independently represent the company to customers and outside agencies including the FDA

Participate in developmental plan meetings

Attend scientific and/or regulatory conferences and develop and cultivate positive relationships

Ensure quality and accuracy of documents

Other duties may be assigned

Qualification

Regulatory submissionsINDsIDEsHDEsNDAsBLAsPMAsGMP complianceBiotechnology knowledgePharmaceutical studies knowledgeWindows operating systemMS Office productsCommunication skillsProject management