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At Gilead Sciences Canada Inc. we take pride in being recognized as one of Greater Toronto’s Top Employer 2024. Click here (http://reviews.canadastop100.com/top-employer-gilead-sciences-canada) to find out why Gilead Sciences Canada is a top employer!

Chez Gilead Sciences Canada Inc., nous sommes fiers d’être reconnus comme l’un des meilleurs employeurs du Grand Toronto pour 2024. Cliquez ici pour (http://reviews.canadastop100.com/top-employer-gilead-sciences-canada) en savoir plus sur les raisons de notre succès.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Regulatory Affairs Senior Associate

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 Role:

We have an exciting opportunity for a motivated & experienced individual to assume the role of Regulatory Affairs Senior Associate on the Regulatory Affairs Canada team to work with highly experienced regulatory professionals across whole product lifecycles in various therapeutic areas. This role will be based at our Mississauga office.

This position will report to the Director, Regulatory Affairs and will be responsible for supporting the preparation of regulatory submissions for investigational and commercial products (eg, Clinical Trial Applications, New Drug Submissions, post-Notice of Compliance changes).

How you will help to ‘Create Possible’:

• Responsible for managing a small product portfolio with guidance from more senior regulatory professionals.

• Participate in regulatory team meetings and present project status updates and provide tactical approaches to addressing issues of moderately complex programs/projects.

• Help identify impact of changes in regulatory legislation and competitor information for assigned product(s) or projects.

• Acts as a knowledgeable resource on limited topics to other Regulatory Affairs personnel within the department.

• Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.

• May initiate or contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.

• Perform document filing and retrieval functions as directed, or in conjunction with departmental SOPs.

• Support the Regulatory Affairs Canada team as required.

Knowledge, Experience & Skills

• Post-graduate certification in Regulatory Affairs is considered an asset.

• Understanding and knowledge of the fundamentals of Canadian regulatory legislation and guidance.

• Excellent planning and organizational skills and the ability to work simultaneously on several projects with tight timelines.

• Must be able to facilitate effective interactions within the Regulatory Affairs Canada Department, as well as with other departments and sites within the Company (for example, Clinical Research and Global Patient Safety).

• Excellent communication skills both in writing and verbally.

• Good judgment/ problem solving skills.

• Strong analytical and assessment skills.

• Methodical attention to detail with accuracy and quality is a must.

• Must be a highly proactive, self-starter with a “can-do” attitude.

• Ability to work under minimal supervision of more senior Regulatory Affairs professionals while following detailed instruction with well-defined procedures.

• 5+ years of relevant regulatory experience in the prescription pharmaceutical industry with experience in clinical submissions. Degree in a scientific field is required.

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.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.