Campus Pride Jobs

Overview

The Senior Director, Regulatory Affairs CMC will be responsible for planning and executing the CMC regulatory strategies for Celldexs therapeutic development programs. This position will manage processes that are required to plan and execute CMC regulatory strategies. The Senior Director will partner with the assigned regulatory liaison for CMC communications and submissions between Celldex and global regulatory agencies.

Responsibilities

• Plan CMC regulatory strategies: define regulatory pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately global BLA approvals.
• Align CMC regulatory plans with cross-functional development and manufacturing teams
• Execute regulatory strategies: track and manage progress within defined timelines, find and manage resources within department and in cross functional teams
• Articulates complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates
• Evaluates proposed manufacturing and quality changes including process transfer, for impact to ongoing and existing filings and provides strategic regulatory guidance for optimal implementation of changes.
• Manage regulatory communications for CMC and related drug delivery devices: be the products primary CMC contact with the FDA and other global regulatory authorities, as required
• Facilitates the development of, reviews, and comments on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, comparability studies, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data including expiry dating and information appropriate to phase of development.
• Manage processes: collaborate cross functionally with teams and departments to generate CMC regulatory documents including reviews and resolution of comments
• Develops and maintains excellent relationships with regulatory authorities, internal functional groups, contract manufacturing organizations and corporate partners
• Other: disseminate global CMC and related drug delivery device regulations and guidelines with appropriate interpretation; assist in developing and managing regulatory budgets and resources; communicate progress, issues, information and performance to plan to senior management and other relevant parties

Qualifications

• Minimum of BS or BA in a scientific discipline, advanced degree preferred
• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements, guidance, accelerated regulatory review paths, and policy trends
• Preparing and executing CMC regulatory development strategies in biologics, experience leading successful BLA submission required, drug delivery device experience preferred
• Industry experience of 10 years, of which at least 8 years spent in regulatory affairs with CMC responsibilities
• Interaction with regulatory agencies, leading FDA CMC development and BLA review meetings required, meetings with global health authorities preferred
• Strong communication and collaboration skills
• Strategic regulatory option development
• Scientific writing in the English language