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Accenture Regulatory Publishing/Submission Senior Analyst in London, United Kingdom

Regulatory Publishing/Submission Senior Analyst (Pharma)

Location: London

Competitive Salary and Package (dependent on experience)

Career Level: Senior Analyst

Accenture is a leading global professional services company, providing a broad range of services in strategy and consulting, interactive, technology and operations, with digital capabilities across all of these services. With our thought leadership and culture of innovation, we apply industry expertise, diverse skill sets and next-generation technology to each business challenge.

We believe in inclusion and diversity and supporting the whole person. Our core values comprise of Stewardship, Best People, Client Value Creation, One Global Network, Respect for the Individual and Integrity. Year after year, Accenture is recognized worldwide not just for business performance but for inclusion and diversity too.

“Across the globe, one thing is universally true of the people of Accenture: We care deeply about what we do and the impact we have with our clients and with the communities in which we work and live. It is personal to all of us.” – Julie Sweet, Accenture CEO

As a team:

This role requires the holder to demonstrate a moderate level of experience in regulatory affairs in the UK. This position defines and produces all high-end publishing tasks and documentation associated with regulatory submissions. This position should have the capacity to grow into a publishing lead and become a role model for the members on the team.

With minimal supervision, the Regulatory Publishing/Submission Senior Analyst supports preparation, validation, and review/QC of regulatory documents. This includes global and country-specific CMC/labelling documents and submission-ready components for major applications and lifecycle submissions. The role also reviews submissions to ensure eCTD standards per Health Authority regulations and guidelines are met, with focus on the technical metadata, submission content, and life-cycle management of the submission/application. Expectations for this role is that it requires enormous attention to detail, willingness to mentor, and initiative to be involved and a motivator for the team and the organization.

You'll learn, grow and advance in an innovative culture that thrives on shared success, diverse ways of thinking and enables boundaryless opportunities that can drive your career in new and exciting ways

If you’re looking for a challenging career working in a vibrant environment with access to training and a global network of experts, this could be the role for you. As part of our global team, you'll be working with cutting-edge technologies and will have the opportunity to develop a wide range of new skills on the job.

As a Regulatory Publishing/Submission Senior Analyst, you will:

  • Assist in review of labeling documents (CCDS/CCSI), and of country- specific labeling documents by using CCDS/CCSI

  • Review CMC documents for original and lifecycle management submissions based on regulatory reviews of technical summaries, quality, nonclinical and clinical study reports, and administrative documents for regulatory filings

  • Conduct regulatory QC reviews of Modules 1- 5

  • Conduct review of complete IND, CTA application eCTD xml backbones for eCTD compliance and accuracy

  • QC/Review IND, CTA documents to ensure they follow eCTD authoring granularity

  • Compile routine investigational and marketed products global maintenance submissions

  • Assist with the filing and approval processes for investigational and marketed products

  • Identify issues (both client and publishing issues)

  • Participate in the development of internal projects

  • Participate in client teleconferences by taking meeting minutes and distributing these minutes to the team members. Be prepared to deploy on-site to support eSUB projects

  • Follow all Internal standards including: Standard Operating Procedures, Guidance Documents and Policies throughout the submission lifecycle

  • Demonstrate the ability to walk a client through the overall publishing process and an explanation of the publishing tools and tasks used to produce electronic submissions

  • Perform Sr. Submission Coordinator tasks in the absence of the team Sr. Submission Coordinator

We are looking for experience in the following skills:

  • Must have proficiency in performing document reviews and quality assurance checks

  • Must have a good understanding of submission compilation and application requirements, and applicable regulations

    Set yourself apart:

  • Master’s degree (or equivalent per geography) in health or life sciences

  • Proficiency with publishing tools and computer applications

  • A general knowledge of the drug development life cycle and the high-level content of a submission.

  • Oral and written capabilities to be reflected in client issue reports

  • Knowledge of EMA or FDA or other region HA /ICH Guidelines

What’s in it for you

At Accenture in addition to a competitive basic salary, you will also have an extensive benefits package which includes 25 days’ vacation per year, private medical insurance and 3 extra days leave per year for charitable work of your choice!

About Accenture

Accenture is a leading global professional services company, providing a broad range of services in strategy and consulting, interactive, technology and operations, with digital capabilities across all of these services. We combine unmatched experience and specialized capabilities across more than 40 industries — powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. With 509,000 people serving clients in more than 120 countries, Accenture brings continuous innovation to help clients improve their performance and create lasting value across their enterprises. Visit us at www.accenture.com

Accenture is an equal opportunities employer and welcomes applications from all sections of society and does not discriminate on grounds of race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, or gender identity, or any other basis as protected by applicable law.

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