Senior Regulatory Affairs Associate (CMC)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 products
• Deliver strategic input on critical cross-project topics, ensuring alignment with overall business objectives
• Develop 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) applications
  • Investigational Medicinal Product Dossiers (IMPDs)
  • Biologics License Applications (BLAs)
  • Marketing Authorization Applications (MAAs)
  • Post-approval variations/supplements
  • Responses to health authority questions
• Author and review high-level regulatory submissions
• Ensure all submissions conform to relevant health authority guidelines and regulations
• Lead submission preparation meetings and coordinate cross-functional input

Health Authority Interactions:

• Lead regulatory CMC discussions and interactions with Health Authorities
• Represent the company in high-level meetings with regulatory agencies
• Develop strategies for addressing complex regulatory questions and issues
• Build and maintain positive relationships with key regulatory stakeholders

Regulatory Assessment and Change Management:

• Oversee regulatory assessments of manufacturing changes
• Establish data requirements and strategies for regulatory submissions related to manufacturing changes
• Provide 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 committees
• Lead critical submission preparation meetings and regulatory strategy discussions
• Address complex reviewer comments and manage sensitive regulatory correspondence
• Provide regular updates to senior management on project status, risks, and key milestones
• Mentor 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 Development
• Facilitate effective communication between internal teams, external partners, and regulatory authorities
• Provide 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 practices
• Drive the development and implementation of innovative CMC regulatory strategies
• Participate in and potentially lead relevant industry groups and regulatory authority initiatives