Job Description

Summary

Responsible for supporting the business and regulatory systems to support submissions such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). Strategizes, designs and implements new ways of working through the enablement of data to support the digital transformation of the Regulatory Operations business.

Job Duties

Supports wider RIM group in the facilitation of business user requirements gathering and the implementation of tools and systems in Regulatory Affairs

Supports development of procedure documents, or best practices for RIM, both from a Regional and Global perspective

Develops and manages business processes and best practices that pertain to Data Management, including, but not limited to xEVMPD/IDMP and other initiatives that address external data standards and vocabularies

Partners with Global Development Solutions to investigate and explore disruptive technologies to enable business efficiencies and opportunities where feasible

Understand and contribute to our end-to-end data workflows from data ingestion and transformation through to outputs (reporting/analytics etc)

Assists with analyzing new RIM technology features and functionality, assists with deployment in collaboration with the Global Development Solutions

Provides insight and guidance to Regeneron stakeholders on Regulatory requirements that pertain to Data and Digital tool adoption (e.g. PLM, CDER NextGen, IRIS)

Supports development, implementing, and managing of Regulatory Information Governance; supports related departmental and enterprise Data Governance programes

Supports audit and inspection activities including retrieval of Regulatory information where required

Assists data steward(s) with implementing data standards to facilitate data quality within RIM systems

Develops and maintains Data Quality frameworks for the monitoring and compliance of data held within RIM systems

Job Requirements

Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc)

Knowledge of pharmaceutical drug and device development process

Knowledge of Data Analytics/visualization tools such as PowerBI, Qlik or Tableau

Thorough knowledge and practical experience with RIM technologies (e.g. Veeva, Calyx, Cunesoft, LifeSphere)

Strong knowledge of categorization and classifying information

Strong knowledge of relationships between key components of Regulatory Information

Experience managing technology projects (e.g. RIM, EDMS, tracking systems, etc)

Strong knowledge of technical writing is required

Experience in SOP writing is preferred

Change management experience preferred

Ability to engage and influence a variety of stakeholders at all organizational levels required

Working knowledge of eCTD and Non-eCTD formats, awareness of submission validation and viewing tools, XML, Microsoft Office suite, and Adobe Acrobat are required. Working knowledge of technical writing is preferred

Minimum Bachelors Degree

Minimum 5 years experience required

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Regeneron Pharmaceuticals