Sr. Manager, Regulatory Affairs

About Climb Bio:

Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates include, budoprutug, an anti-CD19 monoclonal antibody that presents us with an exciting opportunity given its broad potential applicability across a number of B-cell mediated diseases, including systemic lupus erythematosus, immune thrombocytopenia, and membranous nephropathy and CLYM116, an anti-APRIL monoclonal antibody in preclinical development for IgA nephropathy.

At Climb Bio, our team has a knack for seeing what no one else sees—and a drive to achieve results no one expects.  We are seeking a highly motivated Sr. Manager, Regulatory Affairs based at our corporate headquarters in Wellesley, MA.  Reporting to the VP of Regulatory Affairs, this hands-on role involves managing day-to-day regulatory activities, coordinating cross-functional teams, and implementing approaches to navigate regulatory requirements across multiple jurisdictions. The ideal candidate will apply their expertise to ensure regulatory compliance while supporting the advancement of our early-phase clinical programs.

Key Responsibilities:

  • Lead the preparation, review, and submission of regulatory documents including INDs/CTAs, amendments, annual reports, and safety reports to global health authorities
  • Participate in the review of critical documents such as: protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA)
  • Plan and implement regulatory activities to maintain active INDs/CTAs (amendments and annual reports)
  • Serve as the primary regulatory point of contact for assigned development programs, interfacing with cross-functional teams and external stakeholders
  • Implement established regulatory strategies for early-phase clinical development programs in the US, EU, and other key markets
  • Monitor and analyze changing regulations and guidance documents to assess impact on company programs
  • Provide regulatory guidance to clinical, nonclinical and CMC teams throughout development
  • Prepare for and participate in health authority meetings and teleconferences
  • Collaborate with quality assurance to ensure compliance with global regulatory requirements
  • Support or lead non-project activities, as needed (i.e. SOP/standards development, organizational initiatives) for regulatory compliance

Qualifications:

  • Bachelor’s degree required; advanced degree in life sciences, pharmacy, or related field preferred
  • At least 5 years of progressive regulatory affairs experience in the biotechnology or pharmaceutical industry; experience with biologics preferred
  • Demonstrated experience with INDs/CTAs and early-phase (Phase 1-2) clinical trial regulatory requirements
  • Working knowledge of FDA, EMA, and other international regulatory requirements
  • Experience preparing for and participating in health authority interactions
  • Strong project management skills with ability to manage multiple priorities
  • Excellent written and verbal communication skills
  • Ability to interpret complex scientific and regulatory information

This position can be based out of our Wellesley, MA office or remote. Candidates are expected to come on-site to collaborate with the team on an as needed basis. The base salary offered may vary depending on individual’s skills, experience, and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, and stock options.

Qualified candidates are encouraged to forward their resumes to [email protected]

Apply now

Climb Bio is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.