REGULATORY CMC MANAGER

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically 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.

Position Summary

This position supports all CMC regulatory affairs activities for the company’s biologics products and research, provides CMC regulatory input for regulatory submissions, and manages the compilation and review of CMC sections of all submissions for completeness and quality. This role reports to the Associate Director, Regulatory CMC. This position has the potential to be fully remote. Occasional travel will be required for in-person meetings.

Essential Duties And Responsibilities

• Represent Regulatory CMC on cross-functional teams as needed.
• Provide tactical support for the timely preparation, editing and review of CMC submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original BLA/MAA and their respective amendments/supplements.
• Prepare and coordinate portfolio-wide IND, IMPD, BLA submissions.
• Support inspection readiness activities as needed.
• Manage assigned regulatory projects and closely collaborate with personnel from CMC, Regulatory Science, and other scientific departments to coordinate and implement submission strategy and content in a global clinical development environment.
• Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems, as appropriate.
• Coordinate interdepartmental team review and approval of submission document deliverables including: distribute drafts, attend review meetings, and incorporate revisions.
• Assist with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.
• Assist as back-up for NDA related activities, if needed.

Qualifications

• BS, or advanced degree, in life sciences or relevant field. Masters, PharmD, PhD or equivalent is a plus.
• 4+ years of regulatory CMC experience in the pharmaceutical and/or biopharmaceutical industry concentrating on biologics, ADC experience preferred; oncology/rare disease experience a plus and experience with orphan drug development and pediatric drug development desirable.
• Demonstrated understanding of international regulations, processes, and issues in drug/biologics development. Includes sound knowledge of ICH and regional requirements and other relevant guidelines.
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat. Experience with Veeva RIM is a plus.
• Self-motivated and flexible team-member, able to prioritize, multi-task and ability to ‘think outside the box’ in a fast-paced environment.
• Direct experience with pharmaceutical CMC regulatory submissions and product approvals, managing major regulatory filing(s) such as IND/CTA or NDA/BLA/MAA.
• Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices as it relates to CMC activities.
• Demonstrated leadership and success in management of regulatory activities with a proven track record of effective collaboration with regulatory agencies, including the FDA.
• Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
• Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions.
• Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others; prior management experience a plus.
• Outstanding attention-to-detail.
• Familiarity of the multidisciplinary functions involved in pharmaceutical/biotechnology product development.
• Some travel required. Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.

INTERVIEW INTEGRITY

At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.

Compensation And Benefits

The salary range for this position is $120,000 - $140,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary. Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

DISCLAIMER

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

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 a sincerely held religious belief.

We are unable to sponsor or take over sponsorship of any applicant work visas at this time.

Recruitment & Staffing Agencies

Day One Biopharmaceuticals does 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 HR team. 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.