Posted 1 month ago
This is a 12 month contract position:
Job Purpose:
As the Regulatory Affairs Manager, you will lead the development and execution of global chemistry, manufacturing, and control (CMC) regulatory strategies for a wide range of products, including biologics, cell & gene therapies, chemical entities, and devices. This involves preparing and overseeing CMC submissions, representing the company in negotiations with regulatory agencies, and ensuring compliance with evolving regulations. The role involves assessing the impact of new regulations, guiding the development of company policies, and maintaining crucial relationships with regulatory authorities. Additionally, the position drives process improvements for greater efficiency, interacts with internal and external stakeholders, performs compliance audits, and oversees the preparation and delivery of regulatory submissions, both in paper and electronic formats, ensuring compliance with agency requirements.
Details (Your Responsibilities):
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Accountable for a portfolio of products, including the preparation, filing and approval of regulatory submissions throughout the development lifecycle (CTAs, NDSs, SNDSs, NCs, etc.) to aggressive targets
Ensures compliance with applicable Health Canada, industry, and GSK codes and guidelines in alignment with business needs
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)
Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle
Must possess a thorough understanding of the Canadian Food & Drug Acta and 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, Adobe
Preferred Qualifications:
Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs
#LI-GSK
Why Us?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. 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.
As a health and science-based organization, GSK is committed to following the recommendations as set out by Health Canada and taking all necessary steps to help curb the spread of COVID-19 which includes getting the COVID-19 vaccine. We feel strongly that this is the best way to help protect those we value most: our employees, families, communities and the patients and consumers we serve. To that end, we are taking an important step to ensure the safety of our employees during this global public health crisis.
Only employees who are fully vaccinated against COVID-19 may attend our Mississauga and Laval corporate offices. In addition, all customer-facing employees who, as part of their job, attend healthcare settings such as hospitals, pharmacies, doctors’ offices and dentists’ offices will need to be fully vaccinated against COVID-19. Notwithstanding the foregoing, employees may seek an accommodation for human rights-related reasons, including medical or disability-related conditions, or religious beliefs.
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.
Workday in Canada - Ontario - Mississauga
