Senior Director of Regulatory Affairs, Regional Lead (Strategy)

Boston, MA

About Us

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.

Our headquarters are in Planegg, Germany and our U.S. operations are anchored in Boston, Massachusetts. To learn more, visit us at MorphoSys.com, and follow us on LinkedIn and Twitter.

Position Summary

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 driving 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 assigned 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 U.S. 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

Minimum Education/Skills/Experience

  • Hold a Bachelor’s degree in a scientific discipline (required)
  • Advanced degree (preferred)
  • 10+ 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 strongly preferred.
  • 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.
  • Skilled in organizing and carrying 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.
  • Experience in working within a team framework and a multicultural environment.
  • Well organized, scientifically driven, detailed oriented, pragmatic, and open.

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

Health and Safety

Full vaccination against COVID 19 is a requirement for this position.

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.

Reasonable Accommodations

MorphoSys is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at hr-us@morphosys.com

Pay Transparency Policy Statement

MorphoSys US Inc. will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.  However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with MorphoSys US Inc.’s legal duty to furnish information. 41 CFR 60-1.35(c).

Sunshine Act

MorphoSys reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. MorphoSys and potential applicants acknowledge that reimbursement of recruiting expenses for certain licensed healthcare professionals may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a healthcare professional who incurs recruiting expenses as a result of interviewing with MorphoSys that we pay or reimburse, such information may be made publicly available by such government authorities.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Morphosys, US Inc. conducts background screening, reference checks and confirmation of vaccination for COVID-19 as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned.