Manager, Regulatory Information Management (Process and Systems)

Location
Tarrytown, NY, United States
Posted
Oct 12, 2020
Ref
19734BR
Required Education
Bachelors Degree
Position Type
Full time
Summary:
You will be 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 (e.g., FDA, EMA, ICH).

Responsibilities:
* Support development of procedure documents, or best practices for RIM
* Provide business support for all new and existing RIM technology
* Support system validation activities by developing and executing test scripts for systems that support RIM processes
* Assist with identifying RIM related user requirements and use cases (in collaboration with cross-functional stakeholders)
* Provide subject matter expertise on RIM related projects
* Liaise with system and service vendors
* Collaborate with the Regulatory Systems team and key stakeholders
* Assist with RIM technology solution identification
* Assist with monitoring and tracking new functionality (inclusive of enhancement requests) with each new release of RIM
technology solutions
* Communicate key RIM-related information to consumers, collect feedback, and take action
* Analyze new RIM technology features and assist with deployment in collaboration with the Regulatory Systems team
* Assist with providing insight into new regulations, requirements, guidance, and/or specifications relevant to RIM technology
* Assist with developing, implementing, and managing Regulatory Information Governance
* Assist with audit and inspection activities including retrieval of Regulatory information
* Assist RIM Training team with developing RIM-specific training on how to effectively access Regulatory information
* Assist data steward(s) with implementing data standards to facilitate data quality within RIM systems
* May be responsible for supervising staff in addition to implementing employee development plans.

Requirements:
* BS, MS or Advanced degree in a scientific discipline
* At least 8 years of relevant experience
* Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, eCTD, IDMP, UDI).
* Knowledge of pharmaceutical drug and device development process.
* Experience in Regulatory Affairs/Operations/information.
* Thorough knowledge and practical experience in global submissions
* Thorough knowledge and practical experience with RIM technologies
* Knowledge of scientific industry terminology
* Strong knowledge of categorization and classifying information
* Expert knowledge of relationships between key components of Regulatory Information
* Experience managing technology projects (e.g., RIM, EDMS, tracking systems)
* Ability to lead, manage, and/or contribute to multiple ongoing projects simultaneously
* Ability to lead, manage, and/or contribute to improvement initiatives
* Strong knowledge of technical writing is required
* Experience in SOP writing is preferred
* Change management experience preferred
* Knowledge of SDLC methodologies preferred
* Knowledge of 21 CFR Part and Annex 11 Regulations is preferred

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.

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