Regulatory Affairs Manager/Associate Director (CMC)
Are you looking for a role with impact?
Working directly with the Vice President of Regulatory and Quality, the Regulatory Affairs Manager/Associate Director is responsible for all aspects of writing and submitting paper and electronic submissions to regulatory agencies on behalf of Magenta Therapeutics with a focus on CMC. This key position will establish and manage processes 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 regulatory agencies. The Regulatory Affairs Manager 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.
We started with an idea— significant needs remain for patients living with autoimmune diseases, blood cancers, and rare genetic diseases. Bone marrow transplant is a potential cure for many, but its high risks, toxic side effects and complexity prevent many patients from being able to benefit. Magenta is working comprehensively to change the transplant journey for patients.
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.
You are perfect for this role if you are engaged by and want to be responsible for:
- Day-to-day management of regulatory submissions to include filings maintenance, CMC writing, modules processing and circulating for review and approval of all submission deliverables
- Participating in day-to-day meetings / committees / regulatory interactions and providing input to regulatory submission deliverables and objectives as needed to meet the corporate goals
- Assess proposed analytical and manufacturing changes for impact on regulatory filings
- Working with Regulatory, Quality and CMC management to implement internal electronic systems for various documentation workflows and repositing
- 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 CMC. Experience with 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.
- Exercises 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 a successful part of the Magenta Team, 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.
- 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.
- 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 & Excellence