Major accountabilities:
- Provide operational regulatory support for a portfolio of programs.
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Independently coordinate with other groups within RA to finalise and ensure timely dispatch of Health Authority submissions as aligned with assigned program RA sub-teams.
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Contribute to or lead preparation of assigned Module 1 documents including forms and cover letters with oversight of the RA program lead(s).
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Support RA sub-team for clinical trial related activities (CTA forms and tracking, transfer of obligations submissions, drug shipment ticket review, etc.).
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Independently manage assigned regulatory compliance and maintenance activities for clinical trial, registration and post-approval regulatory activities.
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Ensure tracking and update of relevant regulatory information in Novartis compliance systems and trackers as provided by RA sub-team representatives.
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May act as super-user and/or subject matter expert for selected topics or systems.
Minimum Requirements:
- Pharmaceutical experience. Regulatory experience preferred.
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Prior publishing/Regulatory Operations experience preferred.
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Good collaboration and communication skills.
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Fast and flexible, focused on timely delivery and stretch targets.
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Ability to plan and prioritize workload.
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Compliance and quality mindset.
Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: £32,690.00 - £60,710.00
The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering:
https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
Commitment to Diversity and Inclusion / EEO paragraph
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
