Regulatory Affairs Associate (Contract)

GlaxoSmithKline plc; Mississauga; Ibrido; CAD 82.000 - 132.000; Tempo pieno

Descrizione del lavoro

GlaxoSmithKline plc in Canada seeks a regulatory professional to support submissions and regulatory activities for Health Canada. The role focuses on planning, compliance, and coordination with global and local teams to meet tight timelines.

The position requires a B.Sc. in life sciences and experience in regulatory affairs, with knowledge of Canadian regulations and a collaborative, Agile mindset. The role is based in Mississauga with a hybrid on-site/remote model.

Competenze

• B.Sc. in life science or relevant scientific field.
• Some experience in regulatory affairs.
• Understanding of Canadian Food and Drug Regulations and guidelines.
• Knowledge of regulatory requirements for submissions.
• Basic understanding of drug development and commercialization.
• Strong communication and negotiation skills.
• Ability to work on multiple projects and meet timelines.
• Collaborative and adaptable, with change management.

Mansioni

• Assist in planning submissions/activities.
• Prepare regulatory submissions and activities to targets.
• Ensure regulatory compliance with Health Canada and codes.
• Prepare internal reports for Health Canada.
• Coordinate with global and local teams on plans.
• Identify and respond to project issues and regulatory questions.
• Communicate with Health Canada per guidelines.
• Interpret Canadian regulations for GSK activities.
• Experience with Veeva Vault.

Conoscenze

Regulatory affairs

Agile

Communication skills

Negotiation

Team collaboration

Formazione

B.Sc. in life science or relevant scientific field

Graduate degree or Post-Graduate Certificate in Regulatory Affairs

Strumenti

Veeva Vault

Descrizione del lavoro

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

• 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 on-site 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 committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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].

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 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. Find out more on our career site.