Director, Head of Regulatory Operations

DIRECTOR, HEAD OF REGULATORY OPERATIONS

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.

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POSITION SUMMARY:

The Head of Regulatory Operations will be responsible for carrying out the planning, scheduling, and coordination of submission obligations, in collaboration with Regulatory Science colleagues, those from other functional areas within Day One, and outside vendors. Additionally, the Head of Regulatory Operations owns the interface between Regulatory Operations vendors, including definition, planning, implementation of the collaboration, as well as day-to-day vendor oversight and budget management. In addition, the Head of Regulatory Operations will be essential in building and maintaining the future framework of the Regulatory Operations department at Day One and expected to share his/her knowledge and experience with other functional areas as well, in the spirit of continuous improvement.

This position is a fully remote position with occasional onsite business meetings. West Coast candidates preferred.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Manage assigned projects and closely collaborate with personnel from Regulatory Science and other departments at Day One (as with vendors), to coordinate and implement high quality submission output. Be accountable for the management of submission projects, including the preplanning, tracking, assembly, submission, and archiving of regulatory documents

· Using project management and planning tools as required, work to ensure electronic assembly of all submissions are planned, coordinated, and delivered on time, and adhere to company and agency standards

· Utilize current document management and publishing tools to publish dossiers according to regulatory requirements for paper and electronic submissions

· Identify appropriate resources/business strategies needed to support submission publishing activities, including but not limited to research of improved electronic document management systems and/or publishing tools

· Collaborate as a senior member of project teams, meeting regularly to identify and resolve open issues and to assess quality, delivery, and effectiveness, while developing opportunities for business process improvement

· Maintain the submission-tracking process in support of short and long-term submission and resource planning

· Initiate, author and/or collaborate on Standard Operating Procedures, Work Instructions, and Workflows for the Regulatory Operations function; ensure that Company’s practices are in conformance with the latest health authority and industry submission standards

· Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents to ensure that said documents meet requirements as 'Approved for Submission'

· Proactively plan for short, mid and long term Regulatory Operations resources, and strategically plan for a fit-for-purpose team that will grow with the Company

· If applicable, manage the day-to-day activities of direct reports, including project assignments and scheduling (includes career development, conducting performance reviews, providing coaching and guidance). Mentor and train junior staff and other members of the team

· Maintain electronic systems necessary to carry-out functional activities (i.e. eCTD publishing tool, Electronic Submission Gateway)

· Interact and/or negotiate with the FDA and other regulatory agency in interpreting and implementing electronic standards related to eCTD and other submission formats. Source, manage and disseminate Regulatory Guidance pertinent to submission standard cross-functionally

· Perform other related duties as assigned activities

QUALIFICATIONS

· Minimum Bachelor’s degree in Life Sciences or relevant field. Masters or equivalent is a plus

· 8 to 10 years’ experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health);

· Advanced working knowledge of eCTD publishing systems, and relevant publishing tools.

· Extensive knowledge of North American/Global submission standards (FDA, Health Canada, EMA, ICH, GXP, eCTD, etc.), and industry trends for dossier preparation (i.e. IND/CTA/NDA/MAA/NDS).

· Significant track record in leading regulatory operations staff through major global submissions (NDA, MAA etc)

· Proven experience in selection, implementation and use of the appropriate Regulatory Operations systems, vendors, and procedures

· Demonstrated experience in project management and a clear understanding of US and ex-US requirements regarding submission content and format. The ability to multitask and manage multiple and changing priorities. A proven ability to work under pressure and adhere to deadlines

· Computer proficiency in Microsoft Office, including Word, Excel, PowerPoint, Project, and Documentum technology.

· Self-motivated, flexible, and creative leader, able to prioritize, multi-task and work in a fast-paced and demanding environment

· Superior communication skills: oral, written, with proven negotiation skills, and strong time-management. A critical and logical thinker with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.

· Sound understanding of information management concepts and tools needed to carry-out Regulatory Operations priorities, and a practical understanding of evolving technologies in support of all business areas.

· Advanced knowledge of pharmaceutical development (CMC, Nonclinical, Clinical research), with the ability to understand and interpret data/information and its practical application.

· Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.

· Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.

· Experience working with external vendors

· NDA submission experience in a supportive role required, in a lead role preferred

The preceding job description has been designed to indicate the general nature and level of work performed by employees within classification.

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DISCLAIMER

Day One Biopharmaceuticals is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or sincerely held religious belief.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HRteam. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.