경력에 따라 Senior RA Associate - Consultant 레벨 사이에서 채용 고려 예정입니다.

글로벌 RA 경험자 (Australia CMC 경험 포함) 지원 가능

유연한 근무 환경 (풀재택 가능)

Provide strategic direction to late-stage or marketed products, provide strategic input on critical cross-project topics, develop CMC strategies for and author/review regulatory submissions (INDs/IMPDs, BLAs/MAAs, post-approval variations/supplements, responses to questions), ensuring that submissions conform to health authority guidelines.  Lead regulatory CMC discussions and interactions with Health Authorities.  Perform regulatory assessments of manufacturing changes, including the establishment of data requirements for regulatory submissions.  Represent Regulatory CMC at project team meetings, lead submission prep meetings, address reviewer comments, and provide regular updates to Management on project status. 

Strategic Leadership:

Provide strategic direction and oversight for CMC aspects of late-stage and marketed productsDeliver strategic input on critical cross-project topics, ensuring alignment with overall business objectivesDevelop comprehensive CMC strategies to support product development, registration, and lifecycle management

Regulatory Strategy and Submissions:

Develop and oversee CMC strategies for complex regulatory submissions, including:Investigational New Drug (IND) applicationsInvestigational Medicinal Product Dossiers (IMPDs)Biologics License Applications (BLAs)Marketing Authorization Applications (MAAs)Post-approval variations/supplementsResponses to health authority questionsAuthor and review high-level regulatory submissionsEnsure all submissions conform to relevant health authority guidelines and regulationsLead submission preparation meetings and coordinate cross-functional input

Health Authority Interactions:

Lead regulatory CMC discussions and interactions with Health AuthoritiesRepresent the company in high-level meetings with regulatory agenciesDevelop strategies for addressing complex regulatory questions and issuesBuild and maintain positive relationships with key regulatory stakeholders

Regulatory Assessment and Change Management:

Oversee regulatory assessments of manufacturing changesEstablish data requirements and strategies for regulatory submissions related to manufacturing changesProvide expert guidance on CMC-related regulatory implications of proposed changes

Project Management and Leadership:

Represent Regulatory CMC at high-level project team meetings and governance committeesLead critical submission preparation meetings and regulatory strategy discussionsAddress complex reviewer comments and manage sensitive regulatory correspondenceProvide regular updates to senior management on project status, risks, and key milestonesMentor and develop team members in Regulatory CMC practices and strategic thinking

Cross-functional Collaboration:

Work closely with senior leaders across various departments, including R&D, Manufacturing, Quality Assurance, and Clinical DevelopmentFacilitate effective communication between internal teams, external partners, and regulatory authoritiesProvide expert CMC regulatory guidance to support critical business decisions and product lifecycle management

Regulatory Intelligence and Innovation:

Stay at the forefront of evolving CMC regulations, guidelines, and industry best practicesDrive the development and implementation of innovative CMC regulatory strategiesParticipate in and potentially lead relevant industry groups and regulatory authority initiatives