Senior Associate Consultant, Regulatory Publisher

Red Nucleus is hiring a Senior Associate Consultant, Regulatory Publisher to support our Global R&D Operations team! This position can be based out of our London Red Nucleus office, or full-time remote in the UK.

Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific advisory services, and medical communications solutions for the life sciences industry. Our global team is composed of nearly 800 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space.

At Red Nucleus, we believe in providing a rich working environment that pushes us to innovate in ways that engages our employees to be their best selves.  Our culture is about meaningful work, a true sense of community, and fun.  We love to celebrate our people and we are proud to have been Internationally recognized as a “Great Place to Work".    

How You Will Contribute

In this position, you will be working with our Reg Ops team. For more information, please visit Reg Ops I Red Nucleus.

Responsibilities

You will work alongside partners, subject matter experts, and industry specialists to ensure that all client deliverables meet customer expectations. You will be expected to actively contribute to business transformation, process optimizations and system improvements.

The role will require you to represent Red Nucleus in addressing the client’s business requirements and needs including:

• Provide global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information

• Manage regional submissions and support global submissions as a Lead Publisher

• Proactively communicate requirements and issues to be considered to the Submission Team, and contribute to achieving realistic timelines

• Proactively collect necessary information from the Submission Team, and plan all submission management related activities

• Proactively communicate with clients on submission requirements including eCTD

• Liaise with agency experts on electronic submission requirement

• Perform quality checking of documents and regulatory submissions to ensure compliance with submission-ready standards

• Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools

• Analyze submissions and track and record life-cycle information in accordance with standards

• Perform complex searches on submission life-cycle information, as required

• Keep updated on regulatory authorities requirements on technical/format aspects of submissions worldwide and ensure their incorporation into RN standards

• Participate on or lead special project teams (e.g., skill work, standards).

Education, Experience, Training, and Knowledge:

• 5-8 years of experience in the pharmaceutical industry with a focus in Regulatory Operations

• 5-8 years of experience publishing, submitting and managing documents and submissions in a document repository

• Experience assisting in publishing or project managing major (NDA, MAA, etc.) submissions

• Understanding of drug development documents

• At least 5 years of experience with publishing

• At least 3 years of experience with regulatory global registration management information and systems

• Experience assisting with the implementation of a regulatory technology such as, Documentum, First Docs, Insight Manager, Insight Publisher, etc. (Preferred)

• Experience assisting in the migration of documents and submissions from one regulatory system technology to another (Preferred)

• Proficient in Microsoft Suite software including Excel, Word, PowerPoint, Visio

• Bachelors degree preferred

What You Will Enjoy at Red Nucleus

• Competitive pay, incentives, retirement, and income security programs
• Comprehensive benefits and wellness programs focused on healthy lifestyles
• Generous paid time off, employee assistance programs and flexible work arrangements
• Performance driven environment including professional development and transfer opportunities
• People first culture fostering self expression, diversity, and a growth mindset
• Celebrations! We love to celebrate service anniversaries, holidays, diversity and inclusion events, project milestones and anything else that is meaningful to our employees
• Support of the community organizations you are passionate about
• Ongoing programs and events designed to bring our global team together

Diversity, equity and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit.  We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.

To learn more about working at Red Nucleus, please visit Careers | Red Nucleus.

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