City : Calgary

Category : Other

Industry : Healthcare

Employer : GSK

The Regulatory Specialist CTA/IND works within the development delivery function has to ensure that appropriate content for specific submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with GSK process and policy as they apply to the role.

Key Responsibilities:

• Coordination of CTA submissions, to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures
• Accountable to the functional CTA Team Lead for overall work plans and to Global Regulatory Leads or Regional Representatives for definition of requirements within an agreed project
• Accountability for agreed tasks and projects
• Ensure independent communication, with a range of internal GSK staff, in support achievement of the assigned goals
• Ensure compliance with GSK CTA process through timely action and completion of records in internal GSK systems
• Ensure quality of own work to agreed timeframes, including compliance with GSK systems and record keeping
• A good understanding of Clinical Trial Regulation (and Directive), DIA TMF Reference Model and CTA submission requirements for multiple countries/submission types

Why you?

Qualifications:

• Master’s degree or higher in biological or healthcare science
• Biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment.
• Fluency in English
• Knowledge of drug development and manufacturing and supply processes
• Knowledge of worldwide regulatory requirements
• Service orientation, customer focused. A good understanding of EU Clinical Trial Regulation (and Directive), DIA TMF Reference Model and      CTA submission requirements for multiple countries/submission types an ability to work in a matrix environment

Why GSK?

We also offer a wide range of additional benefits:

• Career at one of the leading global healthcare companies
• Replacement Contract Cover
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible.
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure.
• Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits every day

#LI-GSK

#LI-HYBRID

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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.

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