Regulatory Compliance Specialist.

4 weeks ago


Overland Park, United States Altasciences Full time

Regulatory Compliance Specialist

Overland Park, KS, USA Req #4590 Friday, May 3, 2024

Your New Company
At Altasciences we allmove 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.

About the Role The Regulatory Compliance Specialist will be in charge of organizing, filing and tracking all internal regulatory processes. This position will require a wide range of Clinical Research Regulatory knowledge. It will involve but is not limited to filing, managing, and completing essential documents, communicating, and collaborating with multiple internal and external parties, and assisting with completing, managing, and gathering regulatory documents for audits, study readiness, and sponsor visits. What You'll Do Here Coordinate, prepare, or review regulatory submissions and storage for the following documents for domestic or international projects according to SOPs. Creation and maintenance of all regulatory binders  FDA Form 1572 Financial Disclosure Curriculum Vitae Investigator’s Brochures/Acknowledgements Protocol Signature/Acknowledgement Pages IRB Submission Forms Informed Consent Forms Site Signature Logs IND Safety Reports S.A.E. Reporting Amendments to any of the forms listed above Prepare for or participate in audits conducted by study sponsors, federal agencies, or specially designated review groups What You'll Need to Succeed High School Diploma or GED is required and a College Degree is preferred. Excel Spreadsheets Skills Word Processing Skills Internet Navigation Skills What We Offer Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work. Altasciences’ Benefits Package Includes: • Health/Dental/Vision Insurance Plans• 401(k)/RRSP with Employer Match• Paid Vacation and Holidays• Paid Sick and Bereavement Leave Altasciences’ Incentive Programs Include: • Training & Development Programs• Employee Referral Bonus Program #LI-TN1 MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH 

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