Submissions Manager Regulatory Operations
Submissions Manager Regulatory Operations
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Job Description
The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives. Modernas commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients lives worldwide.
Moderna is solidifying its presence within our international business services hub in Warsaw Poland a city renowned for its rich scientific and technological heritage. This hub provides critical functions meeting the growing demand of Modernas global business operations. Were inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.
In the position of Regulatory Operations Submission Manager you will be at the forefront of ensuring the smooth planning management and tracking of regulatory submissions. Your collaboration with the Regulatory Lead will be crucial in planning and preparing highquality global submissions either inhouse or via CRO ensuring timely delivery to global health authorities. This role demands a high level of expertise in regulatory operations to support crossfunctional submission project teams ensuring excellence in planning preparation and delivery of regulatory submissions. You will be the primary contact for major submissions providing vital support and guidance.
Heres What Youll Bring to the Table:
Your key responsibilities will be:
Manage the development and maintenance of a submission content plan tracking documents from authoring to approval publishing and QC.
Act as the global submissions expert ensuring project teams are wellinformed about e submissions (eCTD NeeS etc. and lifecycle management concepts communicating regional differences as needed.
Communicate project status issues schedules and accomplishments to management and stakeholders.
Provide operational oversight for the planning preparation publishing validation and submission of applications (IND NDA MAA etc. updates amendments and variations to global regulatory agencies.
Manage publishing vendors to prepare highquality submission packages and ensure their timely delivery to health agencies.
Your responsibilities will also include:
Maintain technical expertise in regulatory requirements aligning with company processes and client requirements.
Act as a subject matter expert for Modernas document management system.
Compile regulatory submissions and coordinate their distribution to all concerned parties (HA CRO) within agreed timeframes.
Manage submission and product lifecycle information.
Lead and manage special projects as needed.
The key Moderna Mindsets youll need to succeed in the role:
We act with urgency: Your timely management of submissions will be critical to meeting global health authorities deadlines.
We prioritize the platform: Utilizing digital tools and systems will enhance submission efficiency and accuracy.
Heres What Youll Bring to the Table:
A Bachelors degree in a scientific discipline or systems technology or equivalent experience.
58 years of experience in the pharmaceutical industry specifically within 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..
Proficiency in CDISC (ADaM SEND SDTM).
A demonstrated ability to lead and collaborate effectively with crossfunctional teams (Regulatory clinical nonclinical etc..
Excellent document formatting and troubleshooting skills in MS Word and PDF Professional.
At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and wellbeing resources are designed to support youat work at home and everywhere in between.
- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to wellbeing
- Free premium access to fitness nutrition and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary yearend shutdown
- Savingsandinvestments
- Locationspecific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010 we have aspired to build the leading mRNA technology platform theinfrastructure to reimagine how medicines are created and delivered and a worldclass team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission values and mindsets every day our peopleare the driving force behind our scientific progress and our culture.Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.
As we build our company we have always believed an inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit modernatx/careers to learn more about our current opportunities.
Moderna is a smokefree alcoholfree and drugfree work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!
Moderna is committed to equal opportunity in employment and nondiscrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at .
#LIDS2Required Experience:
Manager
Employment Type
Full-Time
