Regulatory Associate

CareAbout•Overland Park, KS

9d•Onsite

About The Position

At Altasciences, we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences. The Regulatory Associate has the responsibility to assist with regulatory excellence for the site(s) that they represent. Ensuring all documentation is in place for the applicable clinical studies, Investigators, facilities, and other employees.

Requirements

High School Diploma or GED required
MS Word, Excel, Outlook experience required.

Nice To Haves

college degree and related work experience preferred.
Minimum 1+ years work experience preferred.

Responsibilities

Coordinate, prepare, and review regulatory submissions
Creation, maintenance, and auditing of clinical study information, investigator site files, and other applicable regulatory documents. (Paper and electronic)
Archival of clinical study information, investigator site files, and other applicable regulatory documents. (Paper and electronic)
Creation and maintenance of: Investigator site files (both paper and electronic), 1572 and financial disclosures, Curriculum vitae, certification, and licensing management of investigators, Investigator’s Brochures, Acknowledgements, Protocol Signature Acknowledgement Pages, Submission Forms, Informed Consent Forms, Protocol Training Logs, Delegation of Authority Logs, Safety Reports, Communications to and from study sponsors, regulatory agencies, federal authorities, health authorities, licensing, and certification boards.
Prepare and participate in audits conducted by internal QA audits.
Prepare and facilitate weekly monitoring visits
Have awareness of regulatory guidelines of related authorities