job summary :

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena.

Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions.

A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more;

the focus is on patient care. If you’re looking to be a part of an impactful team, you won’t be disappointed!

This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.

responsibilities :

Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types Creating timelines for regulatory filings Providing and maintain templates for authoring.

Overseeing authoring and reviewing of regulatory documents 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.

qualifications :

• Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
• Strong organization skills and the ability to track multiple timelines in parallel and manage deadlines.
• Excellent written and verbal communication and ability to collaborate across functions.
• Experience with Veeva Vault systems is preferred.
• Strong team player, self-motivated and able to function independently as well as part of a team
• Able to work on multiple projects concurrently and adapt to a continuously changing environment.
• BA / BS in a scientific field and 2-4 years of proven experience

skills :

MS-WORD, MS-EXCEL, Submissions, QC Review