Upstream Bio
Base pay range
$145,514.00/yr - $177,851.00/yr
Position Summary The Regulatory CMC Manager will influence the execution of global regulatory CMC strategies for Upstream Bio’s investigational products. This role contributes to the preparation and submission of regulatory CMC documentation, and with interactions with Health Authorities for CMC topics. This role also provides regulatory support and guidance to various cross‑functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development programs.
Key Responsibilities
Prepare, review, and submit high‑quality CMC sections of regulatory documents including:
INDs/CTAs, BLAs/MAAs, supplements, and post‑approval variations
Responses to health authority questions related to CMC topics
Contribute to the development of global CMC regulatory strategies and submission timelines in collaboration with internal colleagues and external CROs/CMOs for investigational and/or commercial products
Collaborate closely with Technical Operations and Quality teams to ensure regulatory requirements are met throughout product lifecycle
Perform regulatory assessment and guidance on product compliance topics including change controls, deviations, site inspections, and GMP investigations
Participate effectively on cross‑functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
Participate in regulatory agency meetings (e.g., FDA, EMA) preparation and support
Maintain awareness of global CMC regulatory requirements and trends; proactively assess impact to company products and processes
Qualifications
Bachelor's degree in Biology, Chemistry, Pharmacy or another related life‑science field with 5–8 years of relevant experience in Regulatory Affairs or CMC within the biopharmaceutical industry
Solid understanding of CMC development for biologics
Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
Experience in the preparation, including writing, of CMC modules (3.2.S / 3.2.P) of eCTD dossiers for early‑phase IND/CTA and/or late‑stage BLA/MAA submissions
Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
Strong sense of planning and prioritization and the ability to work with all levels of management
Prior experience in medical devices and combination product development is preferred
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Research
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 upstreambio.com.
*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.
Referrals increase your chances of interviewing at Upstream Bio by 2x
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Position Summary The Regulatory CMC Manager will influence the execution of global regulatory CMC strategies for Upstream Bio’s investigational products. This role contributes to the preparation and submission of regulatory CMC documentation, and with interactions with Health Authorities for CMC topics. This role also provides regulatory support and guidance to various cross‑functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development programs.
Key Responsibilities
Prepare, review, and submit high‑quality CMC sections of regulatory documents including:
INDs/CTAs, BLAs/MAAs, supplements, and post‑approval variations
Responses to health authority questions related to CMC topics
Contribute to the development of global CMC regulatory strategies and submission timelines in collaboration with internal colleagues and external CROs/CMOs for investigational and/or commercial products
Collaborate closely with Technical Operations and Quality teams to ensure regulatory requirements are met throughout product lifecycle
Perform regulatory assessment and guidance on product compliance topics including change controls, deviations, site inspections, and GMP investigations
Participate effectively on cross‑functional teams and may serve as the primary regulatory CMC contact for assigned products and projects
Participate in regulatory agency meetings (e.g., FDA, EMA) preparation and support
Maintain awareness of global CMC regulatory requirements and trends; proactively assess impact to company products and processes
Qualifications
Bachelor's degree in Biology, Chemistry, Pharmacy or another related life‑science field with 5–8 years of relevant experience in Regulatory Affairs or CMC within the biopharmaceutical industry
Solid understanding of CMC development for biologics
Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
Experience in the preparation, including writing, of CMC modules (3.2.S / 3.2.P) of eCTD dossiers for early‑phase IND/CTA and/or late‑stage BLA/MAA submissions
Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
Strong sense of planning and prioritization and the ability to work with all levels of management
Prior experience in medical devices and combination product development is preferred
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Research
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 upstreambio.com.
*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.
Referrals increase your chances of interviewing at Upstream Bio by 2x
#J-18808-Ljbffr