Regulatory Associate

Your New Company!
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 youre a recent college graduate or seeking your next career opportunity its time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role
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.

What Youll Do Here

• 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

  • Investigators 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

What Youll Need to Succeed

• High School Diploma or GED required; college degree and related work experience preferred.

• MS Word Excel Outlook experience required.

• Minimum 1 years work experience preferred.

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

Altasciences Incentive Programs Include:

• Training & Development Programs

• Employee Referral Bonus Program

• Annual Performance Review

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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. Join us at Altasciences!