Regulatory Submission Associate - Student Intern

Job description

Details:
Required Strengths: Project Management / Strategy

The mandate of the Regulatory Submission Associate (SA) role is to support various regulatory submission related activities and other projects within the Regulatory Department. The role will also require the incumbent to contribute to Health Canada submissions, timely feedback & updates and operational excellence activities. The role may require specialization in one particular area, such as CMC or labeling.

We are searching for bold, decisive, innovative team players to add value to Canada's premier pharmaceutical company. If you are an energetic, career-minded professional with a passion for leadership, a focus on solutions, and a commitment to outstanding performance, we invite you to apply to our exciting and rewarding role.

In this position you may participate in:

Submission
• Assist Therapy Area staff in the planning and preparation of regulatory submissions (CTA, NDS, S/NDS, N/C)
• Participate in submission preparation teams
• Assist in various projects within the Regulatory Affairs group

Analysis
• Assist in the regulatory and corporate compliance activities for GSK products
• Participate in the review of regulatory policies and/or guidelines

Liaise with diverse groups
• Regulatory Affairs, Clinical Studies (local & global), Medical Information, Drug Safety & Compliance

Metrics & ad hoc requests
• Collect, extract and analyze divisional performance metrics.
• Participate in ad hoc requests to support departmental or divisional activities.

GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at


Contact information:
You may apply for this position online by selecting the Apply now button.

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jobDetails

Desired profile

Basic qualifications:
This is a 1 year Student Intern contract with a start date of January 2018

Deadline for resume submission: Tuesday, September 26, 2017 (end of business day)

• University Degree Health Sciences eg. Biology, Chemistry, Pharmacology, Toxicology
• Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook.
• Theoretical understanding of Regulatory Affairs and the Drug Development process is required.
• Results oriented with a proven ability to prioritize work and meet challenging deadlines.
• Well developed time-management and multi-tasking ability
• Well developed communication skills including listening, summarizing, probing, clarifying
• Adaptive communication style with ability to influence and build relationships with others across Divisions.
• Proven ability to interact effectively with a diverse group of business partners individually and within a team environment
• Proven ability to deliver to specific deadlines.
• Works with a sense of urgency.
• Diligent, detail oriented.
• Takes Initiative and follows through
• Very good thinking, creative problem solving skills and sound judgment.
• Quick Learner with ability to work in a fast paced and changing environment
• Demonstrated ability to remain calm under pressure

Preferred qualifications:
• University degree in Health Sciences preferred.
• Knowledge of Drug Development and Pharmaceutical Industry is preferred.
• Working knowledge of WebTop is preferred.