Senior Regulatory Submissions Manager

Description:

• This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
• Praxis’s Regulatory team is seeking a Consultant to join our team for approximately 7-8 months.
• We are looking for 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.
• 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.

Requirements:

• Minimum of BS or BA in a scientific or relevant technical discipline
• Experience of 5+ 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; experience with Veeva RIM, Submissions, and Archive required
• 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
• 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.

Benefits:

• Competitive wage
• Flexibility of remote work
• Collaborative team environment
• Impactful and rewarding work

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