About Alltrna 

Alltrna is the world’s first tRNA platform company to decipher tRNA biology and pioneer tRNA therapeutics to treat thousands of diseases. Alltrna unlocks tRNA biology to correct disease. The company’s platform incorporates AI/ML tools to learn the tRNA language and deliver diverse programmable molecules with broad therapeutic potential. Alltrna has an unprecedented opportunity to advance a single tRNA medicine to unify treatment across a wide range of diseases with the same underlying genetic mutation. Alltrna was founded in 2018 by Flagship Pioneering. For more info, visit www.alltrna.com.  

Head of Regulatory Operations

The Head of Regulatory Operations will be responsible for overseeing submission activity for the company’s submission portfolio, with first line accountability for managing the submission forecast. This role will play a pivotal role in supporting regulatory submissions and compliance activities. The successful candidate will utilize in-depth knowledge of global regulatory submission requirements and works collaboratively with other cross-functional departments in providing guidance towards achieving department application filing objectives, identifying areas of concern that are impacting submission timelines, drive process efficiencies and overall operational effectiveness for timely and high-quality regulatory submissions. This individual will provide regulatory leadership and ensure effective communication with business partners and representatives of the US FDA, EMA and other health authorities worldwide. The position reports to the Chief Medical Officer and will be responsible for the future development and growth of the Regulatory operations functional area.

Essential Duties and Responsibilities

• Providing leadership and contributing with hands-on support as needed in managing, planning, coordinating, and preparing all documents submitted to FDA/EMA and other Health Authorities in support of INDs, CTAs, IMPDs, PIPs, BLAs, MAAs as well as Fast Track, Breakthrough, ODD, PRIME, amendments, safety reports, and annual updates
• Serving as overall regulatory operations lead accountable for all regulatory aspects of assigned projects, including development and implementation of the global regulatory development plan for assigned projects
• Works collaboratively with contributing cross-functional team members in order to create and maintain regulatory submission project plans, manages deliverable timelines and activities, ensures alignment on roles and responsibilities, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process ensuring transparency of submission status to key stakeholders and management.
• Ensuring that the regulatory strategy for assigned projects is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate
• Oversees the planning of all regulatory submissions (INDs, NDAs, BLAs, supplemental applications, etc.) in electronic format
• Accountable for the oversight of regulatory submission processes and best practices, bringing clarity to submission timelines and deliverables.
• Provides key insight to identify IT solutions to enhance Regulatory Operations systems (i.e., Project planning tools, Veeva RIM, etc)
• Participates in the writing of regulatory processes (SOPs, work instructions, and/or internal guidelines) and other departmental initiatives to improve standards and systems inter

Qualifications:

• BA/BS degree in a scientific/engineering discipline. Advanced degree a plus.
• Strong understanding of global regulatory requirements and guidelines (FDA, EMA, ICH, etc.) for drug development and submissions.
• Experience with electronic document management systems and regulatory submission software (e.g., Veeva Vault, docuBridge).
• Minimum of 10 years of regulatory experience in the biopharmaceutical industry
• Demonstrated leadership and success in management of regulatory activities with a proven track record of effective collaboration with regulatory agencies
• Regulatory knowledge across therapeutic areas including rare diseases is preferable.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
• Prior experience with FDA and EMA, and success with filing BLAs/NDAs/MAAs. Experience with both early and late-stage drug development
• Experience required with preparing regulatory documents including new INDs/CTAs, Investigator Brochures, DSURs, briefing packages, PIPs and other documents for regulatory submissions worldwide
• Strategic thinker who can balance near term objectives with long term goals and outcomes
• Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience
• Ability to thrive in a collaborative and fast-paced team environment
• Recognized internally and externally as an expert in gene therapy and other biologics regulations, guidelines and precedents related to pharmaceutical development

Our Core Values

1. PATIENTS DESERVE BETTER. We are transforming medicine, boldly building a new future for patients.
2. CURIOSITY SPARKS DISCOVERY. We ardently explore the unknown, catalyzing new scientific breakthroughs.
3. COURAGE PROPELS US FORWARD. We take thoughtful risks without fear of failure, growing with each experience.
4. OUR PURPOSE FUELS US. We each lead and work with focus and passion to design groundbreaking tRNA medicines.
5. WE ARE ONE TEAM. We are united on trust and collaboration, embracing all voices and experiences.

WE GIVE IT OUR ALL, EVERYDAY, FOR PATIENTS EVERYWHERE. WE ARE ALLTRNA.

Flagship Pioneering and our ecosystem companies are 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.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.