Regulatory Affairs Manager, CMC

GSK

View: 132

Update day: 13-02-2024

Location: Mississauga Ontario

Category: Science Labor Pharmaceutical / Chemical / Biotech

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Site Name: Canada - Ontario - Mississauga
Posted Date: Jan 9 2023


Regulatory Affairs Manager, Chemistry, Manufacturing and Controls (CMC)


Job Description Summary

  • Develops and implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout product development and the lifecycle of biologics, cell & gene therapies, chemical entities, and devices.
  • Prepares and directs the development of CMC submissions including initial market registrations, progress reports, supplements, amendments and/or periodic update reports, highlighting risks and mitigation strategies as required.
  • Represents company and negotiates with regulatory agencies in order to expedite approval of pending registrations and respond to agency questions.
  • Assesses impact of new regulations and implements appropriate changes, leads development of company policy and positions on draft regulations and guidance.
  • Accountable for the organization’s awareness of regulatory frameworks and relationships with regulatory authorities/bodies relating to innovation development, product delivery (e.g., registration/promotion) and life-cycle maintenance (CMC/Clinical/Labeling updates, renewals, recalls: maintains license to operate).
  • Ensures awareness of current standards to direct R&D and Commercial on requirements to ensure compliance.
  • Develops/executes strategies to ensure data & document provision/submission in accordance with specific market regulator requirements.
  • Drives process improvements to increase efficiencies.
  • Engages and advances organization positions with internal and external parties.
  • Performs audits to ensure that the organization is in compliance with government laws and regulations.
  • Directs the development of submissions of product registration.
  • Interacts with regulatory agencies to answer questions regarding submissions.
  • Responsible for the preparation, publication, and delivery of paper and electronic components of all submissions. This includes proper formatting bases on the agency requirements.


Primary Responsibilities:

  • 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


Qualifications Required:

  • 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

We’re uniting science, technology and talent to make a difference in more people’s lives, and revolutionising the way we do R&D.

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

No single scientist, nor any one technology can keep us all ahead of disease. That’s why we build important collaborations with commercial and academic partners to advance our understanding of disease and what it takes to get ahead. In the past three years, we’ve doubled the number of partnerships we’ve signed, because of our belief in their significant impact on our process.

Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology and immunology as well at pursuing other science-led opportunities outside our core areas. Many have the potential to be first or best-in-class opportunities for patients and since 2017, we’ve delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do the most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere.

Find out more:

#LI-GSK

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 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 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.

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Deadline: 29-03-2024

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