Associate Director, Regulatory Operations- RIM

Location
Tarrytown, NY, United States
Posted
Nov 17, 2020
Ref
22163BR
Required Education
Bachelors Degree
Position Type
Full time
Accountable for leading, developing, and mentoring members of the RIM Process team, which includes overseeing managers and staff who are responsible for project managing business systems projects; supporting business needs by liaising with internal partners, the Regulatory Systems team, IT, and vendors to identify technical solutions; handling all regulatory information pertaining to regulatory applications and systems.

Works with minimal to no guidance and demonstrates critical thinking. Functions as a contributor as needed.

In this role, a typical day might include the following:

Oversees, leads, mentors, and develops RIM staff who oversees RIM project management

Oversees and drives system improvement projects, ensuring appropriate collaboration with stakeholders

Develops and implements project plans, which includes tracking costs, schedules, risks, and performance for leading projects.

Builds Project Team ownership and commitment to project plans and consistently drives Project Teams to completion.

Leads the Project Team in appropriate decision making through strong judgment and the ability to analyze options and implications.

Actively uses project schedules and other tools to run scenario analysis to provide Teams with options and provide visibility to risks ahead of time to enable in process‑ management.

Assists with developing RFIs and/or RFPs for RIM system projects

Collaborates with the Regulatory Systems team and key stakeholders.

Assists with proactively researching industry and technology trends that could impact current systems and processes.

Leads project vendors to ensure expectations are being met.

Ensures effective collaboration tools are used by Project Team for efficiency.

Develops and implements strategies to ensure effective utilization of RIM system capabilities

Drive development of test scripts and validation of systems that support RIM processes

Develops, implements, and leads Regulatory Information Governance

Develops capabilities to assist RIM system consumers with identifying key information relationships using pertinent metadata

Communicate key RIM-related information to consumers, and collect and act on feedback

Proactively monitor and provide insight into new Regulatory requirements, guidance, and/or specifications relevant to RIM

Collaborate with key stakeholders on the development of an MDM (Master Data Management) solution

Collaborate with stakeholders on the initiation and deployment of an IDMP solution for data collection, data maintenance, and data reporting

Is prepared to assist with audit and regulatory inspection activities
This role might be for you if:

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

Experience with project management methodologies.

Experience in Regulatory Information Management/Regulatory Affairs/Operations.

Knowledge and practical experience in global submissions and principles of RIM technology.

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

Ability to lead, run, and contribute to multiple ongoing projects simultaneously.

Change management experience preferred.

Knowledge of SDLC methodologies preferred.

Strong knowledge of 21 CFR Part 11 and Annex 11 Regulations.

Working knowledge of RIM technology solutions (Veeva Vault preferred), eCTD and Non-eCTD publishing systems, submission validation and viewing tools, XML, Microsoft Office suite, and Adobe Acrobat are required.

Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills

Ability to manage and mentor staff

We seek individuals with proven experience

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.