Title: Director, Regulatory Operations and Information Management
Cambridge, MA
Full time
Job Description:
Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just "treat" people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren't constrained by typical end rails, and we aren't out to just "treat" people. We're all in this for something more. We're driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
The Director of Regulatory Operations and Information Management will lead the Regulatory Operation team responsible for global regulatory submissions and regulatory information management. This includes overseeing all publishing and submission activities to ensure compliance with regulations and adherence to corporate policies, goals, and timelines. This individual will also lead regulatory information management practices, promoting a culture of continuous improvement and cross-functional collaboration. This individual will report the VP, Regulatory Project Management and Operations.
This role requires outstanding interpersonal, communication, and collaboration skills along with the ability to synthesize information and translate it into meaningful strategy.
Provide leadership for document level submission readiness services and act as subject matter expert to assist on eCTD submissions including lifecycle management.
Provide regulatory advice and interpretation of submission regulations and guidance to the Intellia team.
Provide mentoring, guidance, and building a highly functional operations team.
Responsible for the evaluation and selection of publishing outsource providers and leads the regulatory information management initiatives.
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.
Manages, directs, and oversees the regulatory information management strategy, resources, and business practices.
Makes critical decisions that capitalize on opportunities for optimization of information management technologies and effect positive change.
Establish methods and procedures for tracking data quality, completeness, redundancy, and improvement.
Assists with driving the corporate initiative workgroups related to Information Management Systems.
About You:
Our ideal candidate will have participated on a major marketing application team. If you describe yourself as a great partner and team player who wants to have fun and grow with us, we encourage you to apply! Other desired skills include:
Minimum of 10 years pharmaceutical industry experience with at least 3 years of supervisory experience.
Minimum of 8 years of regulatory operations experience and in-depth first-hand experience with producing electronic submissions including eCTD/eSubmissions for all submission types in all regions.
Strong familiarity with metadata management and associated processes.
Working knowledge of pharmaceutical industry-related laws, regulations and submission guidance is essential.
Direct experience in implementing regulatory systems, procedures, and decision support. Veeva RIM preferred
Ability to proactively analyze issues and develop solutions
Demonstrated ability to effectively manage multiple priorities and meet deadlines
Expert knowledge and experience in compiling eCTD/eSubmissions.
Expert knowledge of ICH guidelines.
Expert knowledge of deploying Document Management Systems.
Meet your future team:
The Global Regulatory Affairs group is a rapidly growing and valued team within Intellia and is comprised of respected professionals with diverse regulatory expertise in both large pharma and small biotech settings. The Regulatory Project Management and Operations group is a big part of the GRA function. We are a group of bright, fun, and team first people. Eager to move cool projects forward, we are motivated by the opportunity to make an impact for patients!
The Global Regulatory Affairs group is currently a mix of remote, and hybrid and we are open to applicants working remotely for this role. Although in a virtual environment, the group has made it a priority to continue to foster a sense of community! You can expect to join a hardworking, collaborative environment.
Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.
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.
