Sr. Manager/Associate Director, Regulatory Operations
Reporting to the SVP and Head of Regulatory Affairs, the Sr manager/Associate Director of Regulatory Operations will be responsible for the maintenance and support of regulatory systems used to facilitate the creation of compliant submissions and for the maintenance of regulatory information. They will support the compilation, archiving, and tracking of regulatory submissions and correspondence interfacing with regulatory technology partners.
The Regulatory Operations Sr. Manager/Associate Director is responsible for all operational aspects involved in the preparation and maintenance of regulatory submission documentation. This includes formatting, assembly, submissions and archival of regulatory dossiers and components according to compliant quality standards and prescribed timelines.
This role offers a rare opportunity to the right individual to build a world-class Regulatory Operations department, and be successful in a fast-growing organization with an aspiration to have meaningful impact and improve the lives of patients.
- Assist in compiling regulatory submissions for all assigned projects. Coordinate distribution of submissions to all concerned parties e.g. health authorities, CRO’s, development and commercialization partners, within agreed upon timeframes
- Ensure completion of timely, high-quality submissions, following regulatory guidelines and internal processes
- Organize and maintain submission components associated with a regulatory submission, paper and/or electronic
- Responsible for all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing (non-outsourced projects), production (paper and electronic), and archiving (paper and electronic)
- Create, update and maintain submission templates that meet global regulatory requirements
- Coordinate the receipt and archival of regulatory files (correspondence) transmitted from/to HAs.
- Maintain familiarity with current regulatory submission standards, software validation concepts, and publishing best practices.
- Participate in the development and implementation of regulatory operational systems and software (e.g. document management systems, databases, forecasting tools, etc.)
- Oversee publishing deliverables on a day to day basis to ensure successful execution of operational activities for assigned products
- Coordinates and tracks delivery of required content with content owners for routine / maintenance submissions in all markets
Qualifications and Experience
- Bachelors degree in a scientific discipline or systems technology or equivalent
- 5-10 years experience working in a regulated, life science environment
- Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools
- Extensive knowledge of US and global submission standards, and industry trends for dossier preparation
- A demonstrated ability to lead and/or collaborate with development groups cross-functionally
- Detailed knowledge of clinical and nonclinical data standards
- Expert knowledge of Microsoft Office and Adobe Suite (MS Project is a plus)
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.