Cmc Manager, Regulatory Affairs - Mississauga, Canada - GSK

GSK

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Site Name:
Canada - Ontario - Mississauga, Montreal Queen Street

Posted Date:
Apr

Job Description Summary

Develops and implements Canadian chemistry, manufacturing and control (CMC) regulatory strategies throughout product development and the lifecycle of biologics, cell & gene therapies, chemical entities, and devices, as applicable.
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 lifecycle 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.

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
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 Act and Regulations, relevant guidelines and policies
Must possess a thorough understanding of drug development and commercialization process
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