Regulatory Affairs Jobs at Altasciences | BS Life Science Graduates Apply Now
Altasciences, a leading company in drug discovery, development, and manufacturing, is hiring for Regulatory Affairs Associate jobs in Overland Park, Kansas. This role is ideal for professionals with a background in life sciences who are passionate about regulatory submissions and clinical trial compliance. Join Altasciences to make a global impact while growing your career in a collaborative and innovative environment.
- Job Position: Regulatory Affairs Associate
- Location: Overland Park, Kansas (Remote Eligible)
- Job ID: R101882
About the Company
Altasciences is a global, mid-sized contract research organization (CRO) that collaborates to support the discovery, development, and manufacturing of new drug therapies. By living its values of Employee Development, Customer Focus, Quality and Excellence, Respect, and Integrity, Altasciences fosters a passionate and collaborative work environment. The companyโs mission is to accelerate drug development, ensuring that life-saving therapies reach patients more quickly.
Job Description
The Regulatory Affairs Associate will be responsible for preparing and submitting clinical trial applications (CTAs) to Health Canadaโs TPD, BGTD, and NHPD. This role also involves serving as the regulatory liaison, ensuring compliance, and providing support for regulatory documentation related to clinical research projects.
Key Responsibilities
- Prepare, review, and submit CTAs for small molecules, biologics, and natural health products.
- Serve as the company’s primary contact and regulatory liaison with Health Canada.
- Analyze sponsor-provided information and prepare complete regulatory submissions.
- Manage responses to Health Canada clarification requests.
- Maintain compliance to ensure regulatory requirements are met before trial initiation.
- Handle submission updates (CTA-A, notifications, cancellations).
- Prepare and manage IRB submissions and responses.
- Submit exemption applications for controlled substances.
- Maintain databases for regulatory submissions.
- Ensure timely submission/maintenance of annual clinical documents.
- Provide regulatory support for drugs, biologics, devices, and IND requirements.
- Stay updated on Health Canada and FDA regulatory guidelines.
- Present knowledge gained from workshops and training.
- Represent Altasciences in scientific or business meetings.
Qualifications
- Bachelorโs degree in Life Sciences.
- Strong interpersonal and communication skills.
- Professional attitude with attention to detail and accuracy.
- Ability to work effectively with multidisciplinary teams.
- Knowledge of clinical research, drug development, and regulatory guidelines.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
What We Offer
- Health, Dental, and Vision Insurance Plans.
- 401(k)/RRSP with Employer Match.
- Paid Vacation, Holidays, Sick Leave, and Bereavement Leave.
- Employee Assistance & Telehealth Programs.
- Training & Development Programs.
- Employee Referral Bonus Program.
- Annual Performance Review.
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