Director, Regulatory Information Management

Location
Tarrytown, NY, United States
Posted
Sep 16, 2020
Ref
20073BR
Required Education
Bachelors Degree
Position Type
Full time
The Director, Regulatory Information Management, should be a proven leader who is ready to be both a proactive and responsive RIM leader in a constantly evolving Regulatory landscape. The ideal candidate is comfortable working with stakeholders, colleagues, executive leadership, and is able to influence and evangelize for a wholistic, comprehensive set of systems and processes that comprise RIM.

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

Leads, mentors, and develops RIM staff who are responsible for RIM project management, business analytics, training, and archives/stewardship.
Ensures development, implementation, and maintenance of applicable procedure documents in support of business requirements and in accordance with all applicable Regulatory regulations, guidance, and specifications.
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.
Oversees a team who develops business cases for desired technology and process improvements (in collaboration with stakeholders).
Develops and implements strategies to ensure effective utilization of RIM system capabilities.
Oversees and drives system improvement projects, ensuring appropriate collaboration with stakeholders.
Develops, implements, and manages Regulatory Information Governance.
Proactively research industry and technology trends that could impact current systems and processes.
Ensures staff is prepared to assist with audit and regulatory inspection activities.
Analyzes resource needs and secures additional resources as needed.
Solid understanding of current and emerging Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH, eCTD, IDMP, UDI, etc.).
Working knowledge of pharmaceutical drug and device development process.
Thorough knowledge and practical experience in global submissions and principles of information systems.
Experience managing technology projects (e.g. RIM, EDMS, tracking systems, etc.).
Strong leadership ability and prior experience in a regulatory position within the pharmaceutical industry.

This role might be for you if:

You have a minimum of a Bachelor's Degree.
We seek candidates who possess courage, energy and drive, strong operating skills, strong interpersonal skills, strong strategic skills, and strong team development and mentoring skills.
Additional skills we seek include working independently, the ability to multitask, be self-motivated, well organized, detail oriented, able to prioritize, work well under pressure, has excellent written and verbal communication skills, and knowledge of project management skills.
Working knowledge of Microsoft Office suite, Adobe Acrobat, document publishing tools, electronic document management systems, eCTD publishing systems, eCTD validation and viewing tools, and XML are required. Working knowledge of eCTD authoring templates 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.

-