Regulatory Compliance Specialist

2 weeks ago

Overland Park, United States Alta Sciences Full time

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
* Communication from sponsor e-mail and regular mail
* 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
* Employee Assistance & Telehealth Programs
* Telework when applicable

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

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Altasciences warrants adherence to applicable labor laws, including non-use of forced, prison or child labor, in violation of US and Canada laws, in its operations or supply chain.

Join us at Altasciences

Other details

* Job Family T-4
* Pay Type Hourly

Apply Now

* Overland Park, KS, USA

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