Regulatory Affairs Manager (CMC and/or Oncology)

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.

Key Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: 

• Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area
• Accountable for a portfolio of products, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc) to aggressive targets
• Ensures compliance with applicable Health Canada, industry, and GSK codes and guidelines in alignment with business needs
• For Oncology: Builds trust with Health Canada contacts to improve GSK submission approval times, achieve competitive labelling and resolve product related issues impacting submissions, or compliance activities
• For CMC: Builds trust with Health Canada contacts to improve GSK submission approval times, achieve competitive labelling and resolve product related issues impacting submissions, or compliance activities
• Communicates with and influences multiple local and global functions, to achieve regulatory objectives
• Identifies and responds to issues related to assigned projects and/or products
• Interprets Canadian regulations, guidelines and policies as they apply to GSK regulatory activities
• Mentors junior staff

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)
• For Oncology: Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle
• For CMC: Extensive Canadian CMC Regulatory experience leading multiple submissions at all stages of the product lifecycle.  Experience with small molecules, vaccines, and other biologics is an asset.
• Must possess a thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines and policies
• Must possess a thorough understanding of drug development and commercialization process
• Highly innovative (strategic and functional) and creative problem solver and decision maker who can apply continuous improvement techniques to gain efficiencies in submission preparation, product approval process, and resolving issues
• Agile and able to effectively navigate change
• Demonstrated ability to develop effective regulatory strategies aligned with commercial objectives
• Working knowledge of global regulatory agencies and their practices
• Excellent oral and written communication skills including the ability to present information and contribute ideas in small and large groups
• Good influencing and relationship management skills
• Excellent negotiation skills
• Fully developed project management skills
• Must act with integrity and demonstrate a strong and effective risk management perspective
• 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
• Fosters strong team collaboration, with the ability to engage constructively with others and demonstrate a positive mindset. Open to diverse ideas, styles and perspectives.
• Strong commitment to quality mindset
• Strong computer literacy 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 Regulatory Affairs.

Working Model

This role is based in Canada and is hybrid. You will combine on-site collaboration with flexible remote work.

Ready to apply?
We welcome applications from people who bring scientific curiosity, collaboration and a patient-centered mindset.  If this role aligns with your experience and purpose, please apply now.  We look forward to learning how you can help get ahead of disease together.

GSK uses artificial intelligence (AI) tools as part of the recruitment process to assist in screening and assessing applicants. Final hiring decisions are made by hiring managers, with support from recruiters.

This advertisement relates to a current vacancy.

Skills

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 canada-recruitment@gsk.com.  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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