Director Regulatory Affairs - Regional Lead (Strategy)

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Job Summary

At MorphoSys, we are motivated by our mission: More life for people with cancer. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to redefine how cancer is treated.

Our success is created by our people, and we bring together exceptional talent from around the world, offering our colleagues a collaborative, flexible, and diverse work environment. We are looking for individuals who share our values and are motivated to improve the lives of people impacted by cancer.

Since opening our U.S. office in Boston in 2019, we have doubled in size to support our rapid growth, building teams of experts across a variety of different disciplines, from drug development to commercialization.

To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.

General Accountabilities

The Regulatory Affairs regional lead will develop and implement regulatory strategy leading to successful registration and life-cycle management of new medicinal products. He/She will serve as the Regulatory Lead for the US on relevant projects and work with the regulatory counterpart, located in Germany. The position is a strategic position and reports to the VP, Head of Regulatory Affairs US.

In this role you will:
  • Develop and implement effective regulatory strategies to support projects from Morphosys portfolio to ensure successful registration and life-cycle management.
  • Represent Morphosys as the point of contact with regulatory authorities, including providing support and coordination of regulatory meetings and respective briefing packages development.
  • Provide advice on US regulatory topics for development and marketed products; actively collaborates with cross-functional colleagues within the R&D and technical organizations (e.g., nonclinical, clinical development, biostatistics, manufacturing, quality).
  • Lead and/or review and provide strategic regulatory input to key documents (briefing book, protocol, amendment, IB, protocol, etc.).
  • Lead the preparation, submission, and management of an upcoming NDA in oncology for a NCE.
  • Support the development of the labeling in cooperation with the head of labeling.
  • Key regional strategist member of global regulatory sub-team for the program.  Prepares and executes region-specific aspects of regulatory affairs, and ensures integration into global regulatory strategy
  • Manage IND for assigned products. Coordinate submissions to regulatory authorities and ensure that documents submitted to health authorities are aligned with the regulatory strategy and meet quality standards.
  • Keep management and global regulatory sub-team informed on potential regulatory risk for the project.
  • Monitor the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs
  • Contribute to the development of adequate processes and SOPs to ensure regulatory compliance.

Job Qualifications, Experience and Skills

Job Qualifications, Experience & Skills
  • Hold a Bachelor’s degree in a scientific discipline (required)
  • Advanced degree (preferred)
  • 7+ years of experience with FDA regulatory activities and processes.
  • Demonstrate strong knowledge of drug development and regulatory policies combined with solid scientific and business judgment.
  • Experience in managing IND and FDA liaison / FDA meetings.
  • Prior hands-on experience in filing and leading the registration of a new NCE or NBE in US is a plus.
  • Knowledge of oncology, rare diseases, and co-development of drugs in conjunction with companion/ in-vitro diagnostics is a plus.
  • Excellent communication skills, verbal and written.
  • Ability to organize and carry out diverse activities in a matrix environment often under time pressure.
  • Strong analytical skills to be able to interpret regulatory data and support critical decisions.
  • The ability to work within a team framework and a multicultural environment.
  • Well organized, scientifically driven, detailed oriented, pragmatic, and open.
Health & Safety
Full vaccination against COVID 19 is a requirement for this position.

Culture & Benefits
As a full time employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more.  We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program.  Our culture is a collaborative work environment and we believe the unique contributions each of us brings drives our success. 
 

EEOC Statement

MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices.  We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.