CTA Submission Manager

Novartis; Greater London; Ibrido; GBP 48.000 - 88.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible hybrid working

Parental leave

Insurance plans

Retirement plans

Descrizione del lavoro

Novartis in London is seeking a CTA Submission Manager to steer regulatory activities for clinical trial applications across an assigned portfolio. You will collaborate with study teams, country leads and cross-functional partners to ensure timely, compliant submissions.

The role requires a science degree and at least four years of regulatory experience, with expert knowledge of major country submissions. You will help maintain labeling, safety data interpretation, and contribute to continuous

Competenze

• Bachelor's or master's degree in a science-related field with regulatory experience.
• At least four years' knowledge of regulations and regulatory processes for clinical trials.
• Experience with regulatory submission and approvals across major markets.
• Ability to interpret safety and efficacy data and labeling.
• Experience working in global cross-functional teams in pharma.

Mansioni

• Lead high-quality clinical trial application submissions.
• Build regulatory knowledge across product portfolio and markets.
• Identify regulatory risks and gaps to support timely submissions.
• Coordinate responses to Health Authority queries with cross-functional partners.
• Maintain product information in regulatory systems.
• Support preparation of documents for Health Authority interactions.
• Contribute to continuous improvement in Regulatory Affairs.

Conoscenze

Regulatory submissions

Clinical trial regulations

Cross-functional teamwork

Pharma industry knowledge

Formazione

Bachelor's or Master's in science

Descrizione del lavoro

Salary Range

£47,540.50 - £88,289.50

Job Description Summary

#LI-Hybrid

Primary Location: London, United Kingdom (for candidates residing within 50 miles of the office)

Other Locations: Remote, United Kingdom (UK based candidates living more than 50 miles from the office)

Relocation Support: This role is based in London, United Kingdom. Novartis is unable to offer relocation support: please only apply if accessible.

Help shape the path from clinical development to patients by bringing regulatory precision to every submission. As CTA Submission Manager, you'll manage regulatory activities for clinical trial applications across an assigned portfolio, working closely with study teams, country leads and cross-functional partners. You'll use your regulatory expertise to anticipate challenges, strengthen submissions and help secure timely approvals, while contributing to continuous improvement across Regulatory Affairs.

Job Description

Key Responsibilities

• Lead high-quality clinical trial application submissions, ensuring alignment with regulatory requirements and internal processes.
• Build strong regulatory knowledge across your assigned product portfolio and relevant markets.
• Identify regulatory risks, gaps and trade-offs early to support timely submissions and approvals.
• Coordinate responses to Health Authority queries, developing robust justifications with regulatory and cross-functional partners.
• Maintain accurate product information within regulatory compliance and information management systems.
• Support preparation and finalisation of documentation for Health Authority interactions.
• Contribute to continuous improvement, simplification and automation initiatives across Regulatory Affairs.

Essential Requirements

• Bachelor's or master's degree in a science-related discipline, with relevant regulatory experience and demonstrated capability.
• At least four years' knowledge and experience of regulations, guidelines and regulatory processes for clinical trial activities.
• Experience with regulatory submission and approval processes across major countries.
• Strong experience in planning, execution, regulatory review, compliance, reporting and submission activities.
• Ability to understand and interpret safety and efficacy data and product labelling.
• Experience working effectively within global, cross-functional or matrix teams in the pharmaceutical industry.

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: £47,540 to £88,289

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.

You may be eligible for a company vehicle or a car allowance in accordance with the applicable local Novartis policies and guidelines.

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.

Skills Desired