Director/ Sr. Director, Regulatory Affairs

Location
Cambridge, MA, United States
Posted
Oct 03, 2020
Ref
4879838002
Required Education
Bachelors Degree
Position Type
Full time
Magenta Therapeutics is a clinical-stage biotechnology company developing therapeutics to reset the immune system to cure more patients with devastating and life-threatening diseases. This immune reset approach can be applied through stem cell transplant to multiple diseases, including autoimmune diseases, such as multiple sclerosis and systemic sclerosis; blood cancers, such as acute myeloid leukemia; and genetic diseases, such as sickle cell disease.

Magenta's comprehensive approach to precision immune system reset will transform many aspects of the transplant process, aiming to make it safer and more effective. Our culture is fueled by a driven, passionate group of people committed to making a difference, seizing opportunities for maximum impact and pursuing progress for the patients we seek to serve.

Magenta's comprehensive approach to precision immune system reset will transform many aspects of the transplant process, aiming to make it safer and more effective. Our culture is fueled by a driven, passionate group of people committed to making a difference, seizing opportunities for maximum impact, and pursuing progress for the patients we seek to serve.

The Director/Sr. Director, Regulatory Affairs 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.

The Director/Sr. Director, Regulatory Affairs is responsible for overall regulatory strategy and submission 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 Director must have successfully demonstrated technical proficiency, creativity, initiative, independent thinking and collaboration with others.

You are perfect for this role if you are engaged by:
  • Leading the preparation, cross-functional alignment and communication, and implementation of global regulatory strategies with direct accountability for US, Europe and other geographies, as needed, per corporate objectives.
  • With oversight from the SVP and Head of Regulatory and Quality, acting as primary point of contact to FDA and other regulatory authorities for all Magenta programs and projects. Liaises, negotiates and leads relevant FDA and/or EMA interactions.
  • Providing proactive, innovative thinking and risk-based assessment to inform leadership decisions.
  • Independently leading the preparation and coordination of regulatory submissions. Interacts across the organization to obtain and/or provide information for regulatory submissions.
  • Developing and building strong relationships with Regulatory Affairs team members and regulatory agency personnel, and may interact directly or indirectly with ex-US Health Authorities.
  • Providing regulatory affairs representation on project teams and will be expected to lead regulatory sub-teams, ensuring regulatory strategies and information are aligned throughout the organization.
  • Being accountable for providing timely dissemination of regulatory intelligence, as appropriate to continually educate and inform project team(s).
  • Maintaining a high level of regulatory knowledge and provides regulatory advice to program teams, internal and external partners on development assets and the broader organization.
  • 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
  • Minimum 5 years' (Director) / 8 years' (Sr. Director) 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 ex-US 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.

Successful leaders and contributors within Magenta are:
  • 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
  • Intuitive. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business
  • Collaborative. You will have demonstrated the ability to achieve objectives across complex projects and organizational structures
  • Process-oriented, yet flexible. You will appreciate and be able to create and drive process, while also recognizing when flexibility is needed.
  • 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

At Magenta, we celebrate our differences. We value the power of a diverse array of folks who bring all of themselves to their work. We embrace cultural, cognitive, social, and professional diversity because we know the only way we're going to make new cures possible is by working together.