Senior Director, Regulatory Affairs CMC

New York, NY, USA
Nov 10, 2020
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates is a clinical-stage company focused on the discovery and development of targeted biologic therapeutics. Our proprietary drug platform technology, known as engineered toxin bodies, or ETBs, leverages the resident biology of a genetically engineered form of Shiga-like Toxin A subunit to create novel therapies with potent and differentiated mechanisms of action for cancer and other serious diseases. For more information, please visit MTEM's website at


The Senior Director, Regulatory Affairs CMC will be responsible for planning and executing the CMC regulatory strategies for development, manufacturing, and quality of biologic therapeutics. You will be responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions, IND/Clinical trial applications and BLA applications, Health Authority responses and background packages (including participating in/leading CMC-specific HA meetings). This role requires CMC regulatory expertise through all stages of biopharmaceutical products lifecycle and development of global regulatory CMC strategies for biologic therapeutics. The Senior Director will also perform regulatory assessments of proposed manufacturing changes and provide guidance on regulatory expectations throughout development.

  • Interface with Health Authorities for biologics CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
  • Independently provide phase-appropriate strategic guidance/input related to current regulatory requirements and expectations.
  • Identify, communicate, and propose resolutions to both routine and complex issues.
  • Interpret global regulations and guidance. Identify regulatory opportunity and risks across development lifecycle.
  • Monitor regulatory developments within the biologic therapeutics industry and anticipate and communicate possible global regulatory paradigm shifts.
  • Create and maintain regulatory strategy documents, including response strategy assessments for HA interactions.
  • Review and provide regulatory assessments for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
  • Plan CMC regulatory strategies: define regulatory pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately BLA approvals
  • Align CMC regulatory plans with cross-functional development and manufacturing teams
  • Articulate complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates
  • Evaluate proposed manufacturing and quality changes for impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes
  • Manage regulatory communications for CMC, and be the product's primary CMC contact with the FDA and other global regulatory authorities, as required
  • Facilitate the development of, review, and comment on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data 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
  • Develop and maintain 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

Qualifications, and Required skills:
  • Minimum of BS or BA in a scientific discipline, advanced degree preferred
  • 10+ years of experience in roles in the biotech and/or pharmaceutical industry requiring knowledge of biologic manufacturing processes, cGMP principles, and related FDA and other regulatory guidelines
  • Experience with development, manufacturing, release testing, stability of monoclonal antibodies and fusion proteins drug substance and drug product
  • Knowledge of CMC regulatory requirements across development stages and post-approval is essential. Experience with global CMC regulations for biologics
  • Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements, guidance, accelerated regulatory review paths, and policy trends
  • Mastery of global CMC/GMP regulations (ICH, EMA, FDA).
  • Preparing and executing CMC regulatory development strategies in biologics
  • 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 option development
  • Scientific writing, and strong command of the English language


New York, NY or remote

Reporting Structure:

This position will report to Vice President of Global Regulatory Affairs.

Molecular Templates Inc