Overview
The Manager, Regulatory Affairs CMC, represents Regulatory Affairs on cross-functional teams, working closely with other team members to support corporate and departmental objectives. An important aspect of this role is the planning and management of submissions. Attention to detail in written correspondence, in the maintenance of regulatory files, and ability to work with diverse internal and external stakeholders are also important factors for success in this role.
Essential Functions and Responsibilities
- Manages the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.
- Prepares routine IND and CTA amendments.
- Work with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule.
- Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics.
- Interface with Quality Assurance, clinical manufacturing, commercial manufacturing and other stakeholders to further develop and maintain a robust change control program.
- Work with cross-functional project teams to develop CMC regulatory strategy for product changes at all stages of development.
- Work within the CMC Regulatory Affairs team to gain consensus on proposed changes.
- Negotiate with internal stakeholders to ensure that proposed changes and submission content are aligned with ICH guidelines, country regulations and guidelines, and industry standards.
- Participate in risk mitigation by proactively identifying risk, developing options and contingency plans.
- Assists in developing and managing Gantt charts and trackers for submissions across the multiple products.
- Maintains logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies.
Required Education, Skills, and Knowledge
- BA/BS degree in related field required.
- At least 8 years’ experience in regulatory affairs or a related function in drug/biologic development.
- Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format.
- Broad understanding of international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.
- Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.