Description:

Managing the preparation of regulatory submissions for IND ANDA NDA 510K AdProm and other electronic submission types o Creating timelines for regulatory filings o Providing and maintain templates for authoring. o Overseeing authoring and reviewing of regulatory documents o QC submission documents Contribute to the development of process improvements and procedural documents. Identifying and assessing regulatory risks and risks to timelines. Providing regulatory updates to the project team on different milestones. Working cross functionally with project management operations IT and other functions. Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents. Working closely with other members of the Regulatory team and provide support to their projects as needed. Maintaining archival of submissions and health authority communications in Veeva RIM system. Provide regulatory representation on key meetings including meetings with health agency.

Skills:

Regulatory Affairs, FDA, Regulatory Submissions, IND, NDA, 510K, Pharmaceutical, Medical Device, Quality Assurance

Top Skills Details:

Regulatory Affairs,FDA,Regulatory Submissions

Additional Skills & Qualifications:

BS Degree with 2-4 Years of related Regulatory Affairs experienceUS FDA Experience with Veeva Vault systems is preferred.

Experience Level:

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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