Senior Regulatory Submissions, Manager

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

Position Summary 

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. 

Primary 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 

 Education and Professional Experience 

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

Other Essentials and Key Success Factors  

• 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. 

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.