Head of Regulatory

As Head of Global Regulatory Affairs, you will oversee and drive the U.S. and Global regulatory strategy and operations for Context Therapeutics.

You will partner closely with cross functional leadership, offering regulatory guidance, regulatory risk advice, and leading interactions with regulatory agencies on behalf of Context Therapeutics. Working closely with Manufacturing, Translational Science and Quality functions, you will lead all aspects of the regulatory development strategy, planning and executing program applications from CMC to Clinical.

This position is based out of our headquarters in Philadelphia, PA with at least 2 days per week in the office.

Responsibilities

Job Responsibilities include, but are not limited to:

  • Develop and execute robust US and global regulatory strategies (clinical, non-clinical, CMC) for pipeline planning

  • Provide expert guidance, direction, and leadership on those strategies to the development team and senior management in a collaborative manner

  • Oversee regulatory filings (IND, BLA, etc.) including authorship of critical documents as needed

  • Prepare and execute all meeting requests and briefing documents. Coordinate and prepare teams for Health Authority meetings

  • Interface with regulatory authorities and serve as the primary liaison with regulatory authorities for day-to-day interactions

  • Maintain current working knowledge of US and EU laws, regulations, and guidelines as well as familiarity with the global regulatory environment

  • Identify and collaborate with regulatory experts and consultants

  • Coordinate and prepare responses to requests for information from regulatory authorities

  • Represent the regulatory function on cross-functional development team(s)

  • Establish, update, and implement regulatory policies, standards, and procedures for the company

  • Ensure operations are compliant with FDA, ICH, EMA, and industry standards

  • Manage the regulatory aspects of products and projects including achievement of timelines and deliverables

  • Hire, train and lead the regulatory affairs team to support the growing pipeline

  • Create and manage team budget and resource planning

Requirements

  • Advanced degree in a relevant discipline

  • Experience in immunotherapy required

  • Experience with solid tumors preferred

  • 10-15 yrs of regulatory affairs experience within Biotechnology industry or equivalent experience

  • Direct management experience in leading a regulatory affairs team

  • Strong strategic leadership

  • Experience setting global regulatory strategy

About Context Therapeutics®

Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 bispecific antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody. Context is headquartered in Philadelphia

Context Therapeutics is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.