Senior Regulatory Submissions, Manager

Praxis Precision Medicines, Inc.

11h•Remote

About The Position

Praxis’s Regulatory team is seeking an astute Senior Regulatory Submissions Manager who will oversee the operational aspects of all submissions to U.S. and international Regulatory Agencies. This person will manage the planning, tracking, coordinating, compiling, QC, submitting, and archiving of submissions. They will ensure that submissions are of the highest quality and delivered on-time to meet U.S. and international regulatory requirements and company goals.

Requirements

Minimum of BS or BA in a scientific or relevant technical discipline preferred
Experience of 7+ years pharmaceutical or biotech industry, with basic regulatory operations experience managing the creation and submission of an IND/NDA/BLA
Experience with Microsoft Word, Adobe Acrobat, Smartsheet, electronic publishing software, and electronic document management systems required
Current knowledge of, and experience with eCTD, including expertise with submission publishing tools (eCTD building tools); experience with publishing, validating, and submitting in full eCTD format; knowledge of publishing best practices
Proven ability to function in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, and resourceful
Ability to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project timelines
Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile, team-based environment.
Ability to think critically with a keen sense of urgency and demonstrated problem solving abilities.
Self-motivated, able to influence and guide the work of team members and contribute to a productive and collaborative team environment.
Highly organized and detail-oriented with a passion to deliver quality results.
Strong verbal and written communication skills.
Comfortable with independently making decisions and communicating in a direct fashion.
Approaches his/her work with professionalism, integrity and personal confidence.

Nice To Haves

experience with Veeva RIM, Submissions, and Archive preferred
Experience with Veeva Publishing preferred

Responsibilities

Ensure continuous, compliant and timely regulatory submissions
Create and manage submission content plans in conjunction with Regulatory Affairs strategy and CMC leads, cross-functional colleagues, and global vendors, from initiation through to approval and dispatch, for all Regulatory submissions (IND, IMPD, NDA, MAA, Agency Responses, others)
Publish, validate, and transmit eCTD submissions to the gateway
Track regulatory commitments for assigned products
Schedule and coordinate, with contributing departments, the development of submission deliverables
Communicate directly with functional authors to obtain submission documents in a timely manner
Manage the publication and submission of regulatory documents in electronic common technical document (eCTD) format, and/or paper submissions, when required
Oversee the writing, review, implementation, and continuous improvement of standards, templates, and procedures related to the publishing, review, QC, transmittal, and archiving of paper and electronic regulatory documentation
Develop and maintain best practices, consistent with evolving FDA and international guidelines for electronic submissions
Serve as a contact for the maintenance of electronic document management systems and publishing tool used to support regulatory submissions, identifying system issues, reaching out to the appropriate resources and stakeholders, and coming up with solutions