Director, Regulatory Operations

Location
Cambridge, MA, United States
Posted
Oct 16, 2020
Ref
1458246594
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Our mission:

Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

Leads the regulatory information management (RIM) program for Intellia globally for all of its programs. We are looking for an individual with a skills in strategy, collaboration, and leadership that has a good grasp of the complexities of RIM. This individual should have demonstrated achievements in driving and delivering meaningful changes to support RIM systems implementation.

The position requires a solid understanding of Regulatory Affairs/Operations and extensive hands-on expertise in Regulatory specific technology (e.g. InSight Publisher/Viewer and Veeva Vault RIM), excellent business analysis and project management skills.

This individual will collaborate with Regulatory Affairs team members and other cross-company functions in driving the implementation, development and refinement global regulatory submission processes to support a robust RIM program.

This individual will report to the VP, Regulatory Affairs and Quality. This role requires outstanding interpersonal, communication, leadership and collaboration skills along with the ability to synthesize information and translate it into meaningful strategy.

Responsibilities
    • Translate global RIM-related regulations into meaningful business requirements and solid action plans to support current and future RIM initiatives over the next 3-5 years.
    • Provides leadership and subject matter expertise on Regulatory systems projects.
    • Responsible for the execution and delivery of Regulatory systems projects (new implementations, mergers, upgrades, and enhancements).
    • Support all aspects of the submission, compilation, publishing activities including (but not limited to) user management, training, issue escalation and resolution and working with IT and third-party providers.
    • Oversees vendor staff and manage the day to day work responsibilities related to submission compilation, publishing, electronic submission and archiving.
    • Establish and implement in-house submission publishing and archiving capabilities, including: (1) management of submission publishing software and service providers and (2) development of submission publishing policies and procedures, ensuring compliance with regional and global requirements and standards for regulatory applications in electronic Common Technical Document (eCTD) format
    • Directs highly complex logistical details associated with generating regulatory submissions including project management of IND/CTA/briefing document deliverables.
    • Works independently without appreciable direction and exercises considerable latitude in determining technical and business objectives and assignments.
    • Communicates the status of ongoing projects to internal senior management and across functions as appropriate. Provides support for project roll-outs where necessary.
    • Works collaboratively with IT business partners in the management of enterprise systems, the development and adherence to data standards.
    • Collaborates on technology initiatives and applies leadership skills by working in a global environment with business colleagues across functional teams including (but not limited to) Clinical, Data Management, Information Technology and CMC.
    • Strong knowledge of control and management of regulatory-focused content, throughout the product lifecycle stages, SDLC methodologies and CFR Part 11 and Annex 11 compliance.
    • Expert in the use of Microsoft Office Suite (Word, Excel, Power Point, Project, Visio)


Qualifications
    • B.A./B.S. in the sciences, or health related field with 8-12 years of regulatory experience. S/he should have a track record of successful submissions with the regulatory agencies, and the ability to contribute to the submission of global regulatory applications.
    • Advanced knowledge of Microsoft Word, Adobe Acrobat, electronic document management systems, submission authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required
    • Prior experience with successful IND/CTA/BLA/MAA submissions
    • Excellent communication and organizational skills with the ability to self-manage and meet deadlines
    • Must be highly detail-oriented, resourceful and adaptable to effectively support multiple competing demands and changing priorities


#LI-KD1

What Intellia Stands For:

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us - trusting and counting on every single one of us.

- Explore because we seek new ways to tackle disease. Explore with unbounded minds...free from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

- Disrupt by thinking courageously...and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts...with that breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards...even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.

POSITION: Full-Time, Exempt

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Intellia's web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever's privacy policy .