The Regulatory Affairs Sr. Manager / Associate Director is responsible for submissions preparation and filing to global regulatory agencies on behalf of Magenta Therapeutics, with a focus on clinical development phase I – III. This key position will help establish and manage strategies for drafting, reviewing, approving and submitting documentation, keeping contact logs and databases and managing vendors to achieve corporate objectives, in compliance with Magenta procedures, FDA regulations and those of other global regulatory agencies. The Regulatory Affairs Sr. Manager/Associate Director must have successfully demonstrated technical proficiency, creativity, initiative, independent thinking and collaboration with others.
This role provides the rare opportunity for a growing professional to develop their skills through collaboration with the senior most levels of the organization, while making strategic and tactical impact on the things that matter most – driving our science to help patients.
Magenta Therapeutics is a company dedicated to addressing significant needs across all aspects of transplant medicine with a culture fueled by an amazing, passionate group of people committed to the idea of “patients first” and making a difference.
By pioneering an innovative portfolio of novel therapeutics designed to make the entire bone marrow transplant process more effective, safer and easier, we aim to unleash the full potential of bone marrow transplant for those living with a wide array of conditions such as multiple sclerosis, scleroderma, acute myeloid leukemia, myelodysplastic syndromes, inherited metabolic diseases, and sickle cell disease.
The people at Magenta are at the very core of our progress in pursuing this vision. Our roles don’t dictate our daily activities – every employee is empowered to make an impact, seize opportunity and to develop skills and expertise.
You are perfect for this role if you are engaged by and want to be responsible for:
- Day-to-day regulatory submissions to include filings maintenance, writing, modules processing and circulating for review and approval of all submission deliverables, with a focus on preclinical and clinical content and in compliance with CTD requirements
- Day-to-day meetings / committees and providing strategic oversight to clinical / preclinical regulatory submission deliverables and objectives as needed to meet the corporate goals
- Assess preclinical and clinical protocol designs for regulatory compliance and changes for impact on regulatory filings
- Reviewing preclinical study reports, in conjunction with Pharmacology / DMPK and preparing submission documentation
- Oversight for evaluating and reporting to regulatory bodies, clinical safety reports, in conjunction with Pharmacovigilance and Clinical Operations
- Reviewing clinical study reports for compliance, clarity and readiness for submission
- Working with Regulatory, Quality and Manufacturing management to implement internal electronic systems for various documentation workflows and reposting
- Collaborating cross functionally with all relevant areas to support corporate objectives
We would be thrilled if you brought the following with you:
- BS/BA Degree in a biology or related discipline, advanced degree a plus, 5 to 8 years of relevant experience in regulatory submissions for small molecules, biologics and cell therapies preferred, with a focus on preclinical and clinical development global strategy and execution. Experience with cell therapies, small molecules, and ADC products a plus.
- Fundamental knowledge of eCTD requirements for submission to US and exUS regulatory agencies (IND, IMPD, BLA, NDA, MAA).
- In depth experience using electronic environments for submissions/documentation management.
- Experience preparing for and supporting/attending regulatory agency meetings.
- Working knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these requirements to regulatory submissions and Magenta initiatives.
- Ability to exercise good judgement, problem-solving skills, strong analytical and organization skills; attention to detail required.
- Breadth of knowledge across various functional disciplines to include GMP experience, Quality Systems, GCP and GLP a plus.
To be successful as a leader and team member within Magenta, you must be:
- Driven. You will be focused on the achievement of Magenta’s mission and major corporate goals.
- Results-focused. Demonstrated record of exceeding stretch goals, and willing to bring creative problem-solving skills to challenges along the way.
- Entrepreneurial. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business.
- Intuitive. You will have a demonstrated ability to work in the “gray zone” and anticipate challenges before they arise.
- A proven cross-functional leader. You will have demonstrated the ability to “influence without authority,” build teams, and achieve objectives across complex projects and organizational structures.
- Process-oriented, yet flexible. You will appreciate and be able to create and drive process, and at the same time recognize when rules are meant to be bent.
- Transparent and Articulate. You will have the ability to communicate clearly and concisely with all stakeholders.
- Enterprise-focused and Business-savvy. You will always seek to put the goals of the company first, and help others understand the tradeoffs we need to make across the business. You’ll also be interested in new business development opportunities, being able to bring those to the attention of the right teams at Magenta and able to support those activities as requested.
- Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the company.
- A role model for the company’s cultural pillars; Courage, Commitment and Excellence.