Hiring company: Gilead
Being Here Matters!
At Gilead, Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life-threatening diseases.
We are driven to develop lifesaving products that make a difference for patients around the world.
Every day, we aim to transform the promise of science and technology into breakthrough, innovative therapies that have the power to cure, prevent or treat disease. As a research-based bio pharmaceutical company, we are revolutionizing healthcare by bringing medicines to patients in the areas of unmet need including HIV/AIDS, liver diseases, hematology, oncology, and inflammatory diseases. When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives.
The Position:
Gilead's office in Mississauga, Ontario is seeking a motivated, professional, and experienced individual to assume a full-time employment position in the capacity of Regulatory Affairs Associate II , reporting to the Director, Regulatory Affairs.
Essential Duties and Job Functions:
Provides support in the preparation of regulatory submissions for investigational and commercial products (eg, Clinical Trial Applications, New Drug Submissions, post-Notice of Compliance changes) in line with ICH and Canadian requirements and scientific and company policies and procedures.
May be assigned responsibility for routine labeling and CMC changes.
May contribute to local process improvements, which have an impact on the working of the Regulatory Affairs function or other departments.
May act as a resource on limited topics to other Regulatory personnel within the department.
With guidance from senior Regulatory Affairs professionals, works to develop and acquire required regulatory skills and knowledge.
Work is performed under the supervision of senior Regulatory Affairs professionals following detailed instruction with well-defined procedures.
Helps identify changes in regulatory legislation and competitor information for assigned product(s) or projects.
Knowledge, Experience and Skills:
Requires a degree in a scientific field. Post-graduate certification in regulatory affairs is considered an asset
2-3 years of experience in Regulatory Affairs in the Canadian branded prescription pharmaceutical industry. Knowledge of regulatory requirements, including ICH and Canadian requirements.
Experience with preparation and compilation of CTAs, NDSs, and SNDSs for Health Canada is preferred. Experience in RA CMC is an asset.
Excellent verbal and written communication skills and interpersonal skills are required.
Strong information seeking skills and ability to work under moderate supervision.
Excellent organization skills and ability to work on multiple projects with tight timelines is required.
Attention to detail with accuracy and quality is a must.
Gilead Core Values:
Integrity (doing what's right)
Teamwork (working together)
Excellence (being your best)
Accountability (taking personal responsibility)
Inclusion (encouraging diversity)
Gilead Leadership Commitments:
I AM BOLD in aspiration and AGILE in execution.
I CARE and make time for people.
I LISTEN, speak openly and explain the "why."
I TRUST others and myself to make sound decisions.
I OWN the impact of my words and actions.
We are committed to creating a healthier world for everyone – no matter the challenges ahead of us. Through bold and transformative science, we’re driving innovation that has the potential to become the next generation of life-changing medicines. Our ambition is evident in our mission. Because the impossible is not impossible. It’s what’s next.
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