Senior Director, Regulatory Affairs

This position is responsible for building the regulatory team at Context Therapeutics. The Senior Director of Regulatory Affairs will define and implement innovative regulatory strategies that expedite the development and approval of our portfolio of investigational products. You will act as the regulatory lead on relevant project teams to define and execute development strategies for these programs. You will be the primary contact for interfacing with the FDA and will lead cross-functional teams to deliver both domestic and international regulatory submissions, including IND, CTA, NDA, and MAA submissions. You will hire, coach, and mentor junior regulatory staff to support their development and facilitate program deliverables.

This position is based out of our headquarters in Philadelphia, PA with at least 2-3 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+ years 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.