Regulatory Affairs ,Associate / Project Leader

GSK; Mississauga; On-site; CAD 70,000 - 100,000; Full time

Job summary

A leading biopharma company is seeking a Regulatory Affairs Associate to support and lead regulatory submissions and ensure compliance with Canadian regulations. The ideal candidate will possess a B.Sc. in life sciences and have 1-3 years of experience in regulatory affairs, demonstrating excellent communication and project management skills. Join GSK to contribute to innovative therapies and be part of a collaborative team dedicated to improving health outcomes.

Qualifications

• 1-3 years of experience in Canadian regulatory affairs.
• Good working knowledge of Canadian Food and Drug Regulations.
• Excellent oral and written communication skills.

Responsibilities

• Supports and/or leads preparation of regulatory submissions.
• Ensures compliance with Health Canada and GSK guidelines.
• Collaborates with internal partners to achieve rapid approvals.

Skills

Communication

Negotiation

Attention to detail

Project management

Agility

Creative problem-solving

Education

B.Sc. in life science or relevant scientific field

Tools

Word

Excel

PowerPoint

Outlook

Veeva Vault

Job description

Key Accountabilities/Responsibilities:

• Provides input into and/or develops plans for submissions/activities
• Supports and/or leads the preparation of regulatory submissions (i.e., NDSs, SNDSs, CTAs) to aggressive targets, within a team environment
• Ensures regulatory compliance with Health Canada, industry, and GSK codes and guidelines in alignment with business needs
• Communicates with multiple local and global cross-functional groups to ensure Canadian regulatory needs are met
• Collaborates with internal partners to achieve rapid approval of submissions with optimal labelling, and/or achieve timely completion of projects
• Assists in the preparation of and/or prepares responses to Health Canada requests
• Identifies and responds to issues related to assigned projects
• Interprets Canadian regulations, guidelines and policies as they apply to GSK regulatory activities

Qualifications Required:

• B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
• 1-3 years of experience in Canadian regulatory affairs
• Good working knowledge of the Canadian Food and Drug Regulations, relevant guidelines and policies
• Good understanding of drug development and commercialization process
• Agile with the ability to react quickly, provide creative solutions to problems, and navigate change
• Able to contribute to the development of regulatory strategies aligned with commercial objectives
• Excellent oral and written communication with the ability to present to small and large groups
• Good negotiation skills
• Accountable to simultaneously manage multiple projects and meet tight timelines
• Excellent attention to detail and accuracy of work
• Acts with integrity and demonstrates a strong quality mindset
• Ability to provide and receive feedback, raise issues, share experiences and lessons learned
• Proactive and seeks to constantly learn and develop. Ensures that skills meet changing business needs
• Collaborative with the ability to work with diverse groups of individuals in a team and to express opinions, including as part of group discussions. Open to diverse ideas, styles and perspectives
• Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook, Veeva Vault

Preferred Qualifications

• Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs

*LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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 [e-mail] do not send resumes to this e-mail and instead apply through the online application process of this posting.

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