Job Description

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

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

*LI-GSK

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 . 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.

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