Reporting:

Vice President, CMC

Description:

We are seeking an experienced Associate Director, CMC Regulatory to join Marianas Chemistry, Manufacturing, & Controls organization, advancing personalized medicine and radiopharmaceuticals. This position provides leadership for all quality and regulatory aspects of Chemistry, Manufacturing and Controls (CMC) and assures optimal functioning of internal and external interfaces between CMC, Quality Assurance, Regulatory Affairs and stakeholders for activities across all product development projects. S/he closely interacts with multiple internal and global functions to ensure source data quality, data integrity compliance, manages data integration into secure vault, drafts and creates high quality CMC regulatory submissions that support product development strategy.

Illustrative Breadth of Responsibilities:

• Proactively manages Regulatory aspects of CMC programs including understanding and ability to review internal and external source data for accuracy, quality and data integrity verification for all submissions supporting raw and processed data, reports, method and process validations.
• Responsible and accountable for secure vault data stream, quality and accuracy of all data submitted and system structure quality.
• Proactively manages Regulatory aspects with strong CMC focus, including regulatory documents co-author, document structure and format preparation, ownership responsibility in driving review and resolutions to final document, assure full data integrity of all information entering submission documents and assist global Regulatory Affairs colleagues in submission supporting clinical trial applications and marketing applications appropriate to phase of development.
• Ensures timely delivery of high-quality CMC portion of documents, including regulatory authority requests for information, Investigator Brochure (IB), meeting briefing books, meeting minutes, IND/IMPD/CTA submissions, NDA /MAA submissions, post submission information request (IR), and annual reports, while assuring all documents meet regulatory requirements and quality compliance.
• Supports and complies with procedures established by Quality and Regulatory Operations functions responsible for electronic submissions and document archiving within the Vault to ensure efficiency and complete traceability of all CMC regulatory documents.
• Facilitates the development of, reviews, and comments 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.
• Articulates and resolves CMC issues to project teams and external stakeholders to support global development and commercialization of drug candidates.
• Evaluates proposed manufacturing and quality changes for impact to ongoing and existing filings and provides strategic regulatory guidance for optimal implementation of changes.
• Supports Global Regulatory Affairs team in interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, amendments/supplements/variations, and other submissions which present CMC information.
• Develops and maintains excellent relationships with regulatory authorities, internal functional groups, contract manufacturing organizations, and corporate partners.
• Maintains current understanding of the laws, regulations and guidelines pertaining to CMC/Quality information relevant to RLT development programs.
• Collaborates with VP CMC to identify resource needs, including consultants and new associates advising on skills sets to meet needs.
• Supports VP CMC in other areas of development (clinical and nonclinical) as required.
• Tracks progress against project timelines, generate regular status updates, and communicate progress and issues to management and cross-functional teams.
• Presents findings, assessments and solutions in team meetings.
• Effectively manages workload with minimal supervision.
• Multi-tasks across several projects and manage time effectively to achieve results.
• Collaborates cross-functionally with discovery, non-clinical, clinical, technical operations, quality and regulatory teams.
  

Requirements/Skills:

• Bachelors or Masters degree in science with at least 8 years of relevant growing CMC, regulatory experience working in a GMP environment with strong quality assurance, QMS vault platform operations in the pharmaceutical or biotechnology industry. Experience working with radiopharmaceuticals will be considered as a plus.
• Excellent knowledge of early phase (Phase 0 and Phase I, II) drug product development through validations, global clinical supply and clinical study processes, of cGMP and GCP regulations, ICH Guidelines with ex-US drug product regulations requirements considered as a plus.
• Demonstrated success in managing projects and people in a matrixed environment.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements.
• Understands chemistry manufacturing and controls (CMC) documentation for novel compounds consistent with requirements for eIND, IND, CTA, IMPD, NDA, or other regulatory pathways.
• Demonstrated track record of success in delivering personal and team goals and objectives.
• Strong communication skills, with motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships.
• Ability to work flexible time during final submission preparations in conjunction with global teams in various worldwide time zones.

Mariana Oncologys Principles

• Building a Legacy
• Execution Excellence
• Courage of our Convictions