Regulatory Affairs Associate (Mississauga)

Regulatory Affairs Associate (Mississauga)

06 Nov
|
GlaxoSmithKline
|
Mississauga

06 Nov

GlaxoSmithKline

Mississauga

Are you a curious, team-oriented scientific skilled who wants to build trusted relationships with oncology clinicians and help improve patient care across Canada? GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems. Our diverse portfolio consists of vaccines, specialty medicines, and general medicines. Through continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking treatments that address critical health challenges. This is a 12-month contract, an excellent way to get your foot in the door

Key Responsibilities
- Provides input into the planning of submissions/activities
- Assists in the preparation of regulatory submissions/activities (i.e., NDSs, SNDSs, CTAs, NCs, Training, Compliance, etc) to aggressive targets, within a team environment
- Ensures regulatory compliance with Health Canada, industry, and GSK codes and guidelines in alignment with business needs
- Assist in the preparation of internal reports or responses to Health Canada requests
- Establishes contact and communicates with global and local teams on project related plans and issues
- Identifies and responds to issues related to assigned projects, resolves basic regulatory questions
- Communicates with and may build relationship with Health Canada
- Interprets Canadian regulations, guidelines and policies as they apply to GSK regulatory activities




- Experience working with Veeva Vault Basic Qualifications
- B.
Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
- Some experience in regulatory affairs
- Must possess an understanding of the Canadian Food and Drug Regulations, relevant guidelines and policies
- Must have knowledge of regulatory requirements and processes for all types of submissions
- Must have a basic understanding of drug development and commercialization process
- Agile with the ability to react quickly, provide creative solutions to problems, and navigate change
- Good oral and written communication skills
- Some demonstrated negotiation skillsAccountable to simultaneously work on multiple projects and to 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
- 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
- Competence with electronic business environment and computer skills including Word, Excel, PowerPoint, Outlook Preferred Qualifications
- Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.



Working Model This role is based in Canada and is hybrid out of our Mississauga location. You will combine in office collaboration with flexible remote work. Skills
- Agile Planning
- Business Acumen
- Change Management
- Digital Fluency
- Learning Agility
- Problem Solving
- Regulatory Strategies In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD82,000 to CAD132,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re c

📌 Regulatory Affairs Associate (Mississauga)
🏢 GlaxoSmithKline
📍 Mississauga

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