Sobi - Swedish Orphan Biovitrum AB (publ)

Global Regulatory CMC Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Job Level

Senior

About the role

  • Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include CMC information
  • Write and compile CMC sections of regulatory submissions including clinical trial applications and variations/supplements as well as registration submissions worldwide
  • Lead team of SMEs through extensive knowledge of eCTD requirements for Quality modules with respect to marketing authorization, post approval changes and clinical trial applications globally
  • Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to understand regulatory impact of the risks identified to aid with mitigation and informed decision making
  • Manage answers to questions from the Health Authorities in a timely and effective manner to ensure early approval
  • Interact and negotiate with Health Authorities on CMC issues
  • Develop and maintain project plans and schedules for CMC submissions
  • Evaluate proposed manufacturing changes for global impact assessments and provide regulatory strategies that support change implementation
  • Provide guidance on ICH, FDA, and EU CMC guidelines
  • Develop and maintain strong relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory objectives
  • Represent the Regulatory Affairs CMC function on assigned cross-functional project teams
  • Ensure all CMC dossiers and relevant regulatory information are stored in Veeva according to Sobi’s guidelines

Requirements

  • BSc in Life Science is required.
  • Advanced Degree preferred
  • At least 7-10 years of experience are required in CMC Regulatory Affairs.
  • Demonstrated expertise in global regulatory CMC requirements, including contents of Quality sections
  • Experience in the new product registrations and CMC lifecycle management
  • Experience in CMC development during clinical phases is beneficial
  • Ability to manage interactions with Health Authorities
  • Strong working knowledge of global regulatory guidelines
  • Fluency in English
  • Effective verbal and written communication skills
  • Highly computer literate (Word, Excel PowerPoint), including formatting and getting document submission-ready
  • Experience with Veeva is preferred
Benefits
  • Competitive compensation for your work
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Opportunities for professional growth
  • Diversity and Inclusion
  • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CMC strategiesregulatory submissionseCTD requirementsdossier preparationmanufacturing changesICH guidelinesFDA guidelinesEU guidelinesCMC lifecycle managementclinical phases CMC development
Soft Skills
negotiationstakeholder managementdecision makingrelationship buildingcommunication skillsproject managementrisk identificationteam leadershipeffective verbal communicationeffective written communication
Certifications
BSc in Life ScienceAdvanced Degree