Sr. Specialist, Regulatory Operations

Moderna

Warsaw, Poland

The Senior Submissions Specialist, Regulatory Operations is a vital part of our global Regulatory Operations team. In this role, you will coordinate and track regulatory submissions, partnering with the Regulatory Lead to prepare high-quality global submissions and ensuring timely delivery to health authorities worldwide. You will provide operational support to cross-functional submission teams, driving excellence in planning, preparation, and compliance, while serving as the key point of contact for project and submission activities.

Here’s What You’ll Do:

Your key responsibilities will be:

Coordinating the development and maintenance of a submission content plan with guidance from senior Regulatory Operations personnel.
Ensuring project teams understand and align with global e-submissions standards (eCTD, NeeS) and life cycle management concepts, while navigating regional differences effectively.
Providing operational support for the planning, preparation, publishing, validation, and submission of applications such as BLAs, MAAs, and Variations, and ensuring their timely delivery to global health authorities.
Leading and coordinating activities with publishing vendors to produce high-quality submission packages.
Collaborating on special projects and driving operational excellence in all submission-related processes.

Your responsibilities will also include:

Maintaining technical expertise of regulatory requirements to ensure compliance with company and client standards.
Managing distribution of submissions to health authorities, CROs, and other stakeholders within agreed timeframes.
Effectively communicating project status, schedules, and deliverables to management and stakeholders.

The key Moderna Mindsets you’ll need to succeed in the role:

We act with urgency: In regulatory submissions, timely and accurate delivery saves lives. You'll thrive in fast-paced environments where responsiveness is crucial.
We behave like owners: Taking full accountability for your projects, you’ll own the success of submission strategies, embodying a solutions-oriented mindset.

Here’s What You’ll Bring to the Table:

Bachelor’s degree in a scientific discipline or systems technology or equivalent.
3-5 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health).
Working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools (Veeva RIM).
Working knowledge of European, EEA, Western Europe, US, and ROW electronic submission standards and industry trends for electronic submission requirements.
Knowledge of SPOR, and IDMP requirements.
A demonstrated ability to collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.).
Strong attention to detail and ability to work in a fast-paced environment.
Excellent document formatting/troubleshooting skills in MS Word/PDF Professional.
Excellent English Language Skills.

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