(Contract) Submissions Manager, Regulatory Operations
ModernaTX, Inc.

Job Info

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The Role:

The Regulatory Operations Submission Manager is responsible for the planning, managing, and tracking of regulatory submissions. In collaboration with the Regulatory Lead, he/she plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The Submission Manager provides regulatory operations expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation, and delivery of regulatory submissions, and acts as the primary point of contact for project and/or submission teams for major submissions.

Here's What You'll Do:

• Manage the development and maintenance of a submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing, and QC.
  
• As a global submissions' expert, ensure the project team has awareness and knowledge of e-submissions (eCTD, NeeS, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.
  
• Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed.
  
• Provide operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (IND, NDA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.
  
• Manage activities of the publishing vendors in preparation of high-quality submission packages and their timely delivery to health agencies.
  
• Maintain technical expertise of regulatory requirements and ensures alignment with company processes and client requirements
  
• Act as a subject matter expert for Moderna document management system.
  
• Compile regulatory submissions. Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed upon timeframes. Manage submission and product life-cycle information.
  
• Lead and manage special projects as needed.
  

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

• Bachelor's degree in a scientific discipline or systems technology or equivalent
  
• 5-8 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health)
  
• Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools
  
• Extensive knowledge of North American/Global submission standards (FDA, Health
  
• Canada, EMA, ICH, eCTD, etc.) and industry trends for dossier preparation (INDs, CTAs, etc.)
  
• Knowledge of CDISC (ADaM, SEND, SDTM)
  
• A demonstrated ability to lead and/or collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.)
  
• Excellent document formatting/troubleshooting skills in MS Word/PDF Professional.
  
• MS PowerPoint skills
  

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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