CTA Submission Manager

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.; Greater London; Ibrido; GBP 48.000 - 88.000; Tempo pieno

Descrizione del lavoro

Novartis Pharmaceuticals UK Ltd. is seeking a CTA Submission Manager to oversee regulatory activities for clinical trial applications across an assigned portfolio.

You will work with study teams, country leads and cross-functional partners to anticipate challenges and strengthen submissions for timely approvals. Responsibilities include leading submissions, coordinating Health Authority responses, and ensuring regulatory information is accurate and compliant.

Competenze

• Bachelor’s or master’s degree in a science-related discipline.
• At least four years’ experience with regulatory processes for clinical trials.
• Experience with regulatory submission and approval across major countries.

Mansioni

• Lead high-quality clinical trial application submissions.
• Coordinate responses to Health Authority queries with cross-functional partners.
• Maintain product information in regulatory information systems.
• Contribute to continuous improvement in Regulatory Affairs.

Conoscenze

Regulatory knowledge

Regulatory submissions

Cross-functional teamwork

Regulatory compliance

Formazione

Science degree

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.

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.

Skills Desired

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

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

• 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.