Regulatory Affairs Senior Associate
Regulatory Affairs Senior Associate
Canada - Ontario - Mississauga
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory conditions.
We have an exciting opportunity for a motivated, experienced individual to assume the role of Regulatory Affairs Senior Associate in 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 an Associate Director 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).
- 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.
- Post-graduate certification in Regulatory Affairs is considered an asset.
- Understanding and knowledge of the fundamentals of Canadian regulatory legislation and guidances.
- 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 - experience in both clinical and CMC considered an asset. Degree in a scientific field is required.
For Current Gilead Employees and Contractors:
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Canada---Ontario---Mississauga/Regulatory-Affairs-Senior-Associate_R0017172
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