Associate Director, Regulatory Affairs

The Associate Director, Regulatory Affairs is responsible for providing strategic regulatory leadership to support the development and execution of regulatory processes to ensure timely approval of products with favorable labeling that meets the needs of the business, markets, and patients. This role requires a solid understanding of global regulatory science, drug/biologic development processes, and the ability to collaborate cross-functionally to influence key stakeholders.

This individual will work closely with cross-functional teams to contribute to the global regulatory strategy and ensure compliance with applicable domestic and international regulations.

Key Responsibilities:

• Oversee preparation, review, and submission of regulatory dossiers (INDs, CTAs, BLAs, MAAs) by ensuring accuracy and compliance of regulatory documents and managing timelines.
• Serve as the regulatory lead on cross-functional Product Development Teams by providing strategic guidance on regulatory risks and mitigation plans.
• Lead and manage interactions with regulatory authorities (FDA, EMA, MHRA) including preparation of briefing documents and meeting materials.
• Contribute to the development of regulatory SOPs and the implementation of regulatory platforms (i.e. Veeva systems) to enhance regulatory processes.
• Monitor changes in the regulatory environment and provide guidance to internal teams to ensure compliance.
• Contribute to the development and communication of regulatory strategies for assigned projects, ensuring appropriate documentation and review.

Qualifications:

• Science degree in a science-related field or equivalent experience.
• 8-10 years of experience in regulatory drug development.
• Experience interacting with global health authorities including preparation for health authority interactions (e.g., Scientific Advice, Pre-NDA/BLA meetings).
• Proven experience leading regulatory strategies and submissions.
• Strong understanding of regulatory processes and requirements within one or more therapeutic areas.
• Ability to evaluate regulatory risks and contribute to strategic decision-making.
• Excellent communication, collaboration, and organizational skills.
• Demonstrated ability to work effectively in cross-functional teams and manage multiple priorities.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD).

Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at

Compensation

Target Salary Range: $188,100 -$229,900

* Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.