Associate Director Regulatory Information Management - Training

Location
Tarrytown, New York
Posted
Mar 20, 2018
Ref
12699BR
Required Education
Other
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

Responsible for leading RIM training team who provides training on RIM processes, systems, and tools that support compliance with applicable Regulatory Agency regulations, guidelines, specifications (eg, FDA, EMA, ICH, etc), and internal policies and procedural documents.
Requires minimal guidance from direct manager.
Requires to function as a contributor as needed.
Provides support and backup to management as needed.
Will be responsible for supervising staff in addition to implementing employee development plans.

Duties:

Responsible for Implementing training strategies to ensure effective utilization of RIM capabilities.
Responsible for training on RIM-related processes, systems, and tools.
Responsible for providing training on drug development essentials, and updated Agency Regulations, guidance, and specifications.
Responsible participating in RIM-related system projects and developing new training materials as needed.
Responsible for applying a change management process and tools to create a strategy to support adoption of the changes required by a project or initiative.
Responsible for creating RIM awareness by designing, developing, marketing and distributing RIM-related communications.
Assist with conducting RIM-related impact analyses and assessing change readiness.
Provides leadership and subject matter expertise on RIM-related projects.
Communicates regulatory system enhancements and technical issues to key stakeholders.
Manage vendors who support RIM-related training.
Assists with regulatory inspection activities.
Communicates the need for additional resources to management as needed.

Requirements:

Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
Requires strong knowledge of training.
Knowledge of pharmaceutical drug and device development process.
Knowledge of scientific industry terminology and how to effectively use in training.
Ability to lead, manage, and/or contribute to multiple ongoing projects and improvement initiatives simultaneously
Change management experience required
Ability to engage and influence a variety of stakeholders at all organizational levels required
Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
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. Working knowledge of technical writing is preferred.
Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills
Will be responsible for supervising staff.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Requisition Number: 12699BR