Regulatory Affairs Associate (Contract)

Are you a curious, collaborative scientific professional 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 This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:  ·         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 ·         Assists 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   Why you? Basic Qualifications:   We are looking for professionals with these required skills to achieve our goals:  ·         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 skills ·         Accountable 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 ·         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 ·         Competence with electronic business environment and computer skills including Word, Excel, PowerPoint, Outlook   Preferred Qualifications:   If you have the following characteristics, it would be a plus: ·         Graduate degree and/or Post-Graduate Certificate in Reg