CMC Regulatory Affairs Associate II

3 weeks ago

Mississauga, Canada Gilead Sciences, Inc. Full time

CMC Regulatory Affairs Associate II page is loaded CMC Regulatory Affairs Associate II Apply locations Canada - Ontario - Mississauga time type Full time posted on Posted Yesterday job requisition id R0040389

At Gilead Sciences Canada Inc. we take pride in being recognized as one of Greater Toronto’s Top Employer 2024. Click here 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 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. Join Gilead and help create possible, together.
Job Description

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:

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 CMC Regulatory Affairs Associate II , reporting to the Senior Manager, Canada CMC Regulatory Affairs.

Essential Duties and Job Functions:

  • Responsible for preparing and submitting regulatory documents which require interaction with departments in and outside of CMC Regulatory Affairs for investigational and commercial biologics and small molecule products, in line with ICH requirements, regional requirements and scientific and company policies and procedures.

  • Responsible for CMC submissions which may include CTAs, notifications & amendments, and SNDSs and for contributing to NDSs for assigned projects. Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs and work instructions. Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to key stakeholders.

  • Coordinate and author responses to submission review questions from Health Canada and negotiate with Health Canada on timelines and response requirements.

  • Performs CMC change control assessments against Canadian regulations and guidances

  • Responsible for actively participating in cross-functional project teams and for representing Canadian regulatory requirements on Regulatory Project Teams. May contribute to regulatory strategy and filings outside of Canada.

  • Maintains knowledge of regulatory requirements and communicates changes in regulatory information to line manager and regulatory project teams in a timely manner.

  • Work is performed cross-functionally within a matrixed organization. under supervision of senior line manager.

  • Participate in group meetings and provide tactical approaches to addressing problems of moderate complexity.

  • Contribute to local process improvements, which have an impact on the working of the CMC Regulatory Affairs function or other departments.

Knowledge, Experience and Skills:

  • BS/BA degree in scientific field preferred and 4 years of relevant pharmaceutical/biotech industry experience, for example in CMC Regulatory Affairs.

  • Excellent organizational skills and ability to work on multiple projects with tight timelines is required.

  • Excellent verbal and written communication skills and interpersonal skills are expected.

  • Must work well under demanding deadlines and have excellent attention to detail.

  • Must have a reasonable understanding of regulatory requirements, including ICH and Canadian requirements.

Gilead Core Values

  • Integrity (doing what's right)

  • Teamwork (working together)

  • Excellence (being your best)

  • Accountability (taking personal responsibility)

  • Inclusion (encouraging diversity)

Gilead Leadership Commitment

  • 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.

About UsJoin an Award-Winning Team

At Gilead Sciences Canada Inc. we take pride in being recognized as one of Greater Toronto’s Top Employer 2024. Click here to find out why Gilead Sciences Canada is a top employer

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