Manager, Regulatory Operations
The Regulatory Operations Manager is responsible for all operational aspects involved in the preparation and maintenance of regulatory submission documentation. This includes formatting assistance, assembly, and archival of paper and electronic submissions and submission components according to quality standards and defined timelines. Also, responsible for other tasks as assigned.
Here's What You'll Do:
- Assist in compiling regulatory submissions for assigned submissions. Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed upon timeframes. Manage submission and product life-cycle information.
- Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within time lines.
- Organize and maintain submission components associated with a regulatory submission, paper and/or electronic, as required. This may include, but is not exclusive to, setting up templates and Binder templates, scanning, printing, and indexing.
- Responsible for all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing (non-outsourced projects), production (paper and electronic), and archiving (paper and electronic), as applicable.
- Create, update and maintain submission templates that meet global regulatory requirements
- Coordinate the receipt and archival of regulatory files (correspondence) transmitted from/to HAs.
- Maintain familiarity with current regulatory submission standards, software validation concepts, and publishing best practices.
- May participate in the development and implementation of regulatory operational systems and software (e.g. document management systems, databases, forecasting tools, etc.)
- Perform administrative functions as directed by Management.
- Support regulatory documentation users and contributors.
- Act as interface with external publishing partners
Here's What You'll Bring to the Table:
- Bachelors 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
Here's What We'll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP.
- Flexible Spending Accounts for medical expenses and dependent care expenses.
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.