What are the responsibilities and job description for the Regulatory Manager position at Upstream Bio?
Position Summary :
The Regulatory Affairs Manager is responsible for supporting the development and execution of regulatory strategies 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 :
- Contribute to the development and implementation of regulatory strategies to support product development and approval.
- Collaborate cross-functionally to ensure alignment of regulatory strategies with business objectives and patient needs.
- Support the preparation and submission of regulatory dossiers.
- Serve as a Regulatory Affairs representative on Product Development Teams and ensure effective communication of regulatory requirements.
- Support the planning and execution of health authority interactions, including preparation of briefing documents and meeting materials.
- 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 :
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 verekitugs unique attributes to address the substantial unmet needs for patients underserved by todays standard of care. Learn more about us at upstreambio.com.
