CMC Development Regulatory Associate Full Time Permanent

Purpose:

The purpose of the CMC (Chemistry, Manufacturing, and Controls) Regulatory Associate leads the operational and technical aspects of clinical trial and global marketing authorization submissions for the small and large molecule portfolios in partnership with the Global Regulatory Affairs CMC Regulatory Scientists. The Regulatory Associate partners with the GRA-CMC Scientists to create and manage submission documents and provides guidance on structure and content placement. The Regulatory Associate works within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.

This is accomplished by a strong working knowledge of customers, internal procedures, regulatory guidance and precedence. The Regulatory Associate triages and manages communications between mi client’s global  Affiliates, GRA-CMC Scientists, CMC teams, Clinical teams, and Quality/Regulatory Representatives. The Regulatory Associate utilizes submission process expertise to facilitate project management expectations across projects. The scope of work includes global regulatory requirement assessment and understanding strategy development in relation to submission management.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.  Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Regulatory & Drug Development Expertise

• Partner with the CMC Regulatory Scientists to drive the execution of submission planning for clinical trials and global registration submissions. This includes defining key requirements for individual countries and managing questions from affiliates and agencies, establishing and monitoring content due dates, and executing the integrated regulatory strategy to ensure timely submissions.
• Review regulatory strategies across molecules and identify opportunities to simplify and streamline submissions for markets and/or regions.
• Interpret and implement global agency regulations, guidance and regulatory precedence into submission processes and publishing standards to ensure final document content and structure are compliant with local regulatory requirements.
• Lead CMC submission management process by providing expertise on internal processes, electronic submission regulations and guidance regarding technical content and structure requirements.
• Own the submission management process at the molecule/project submission level to ensure all required electronic records are timely, complete, and accurate. 
• Serve as the CMC operational lead for global clinical trial applications and registration planning and execution, including critical chain status updates. Own execution of the right to operate routine compliance submissions, such as CMC annual reports (i.e. DSURs).
• Understand and support the regulatory processes that enable review and release of clinical trial materials.
• Manage CMC databases and/or information tools, prepare periodic or special request submission metrics reports to enable CMC staff to identify and address global agency trends.

Lead, Influence, Partner

• Lead CMC submission management processes by leveraging expertise to optimize internal processes and tools. Anticipate and resolve process and/or timeline issues.
• Develop collegial and mutually productive relationships across my client’s components, partner companies, Affiliates and regulatory submission centers that enable a team environment of developing quality submissions in a timely fashion.
• Partner with the Regulatory Scientist to plan, facilitate and document internal regulatory draft review meetings, and/or submission integration/planning sessions.
• Lead communication and transfer of registration submission commitments between GRA-CMC and Site Regulatory Affairs groups.
• Create an environment within Global Regulatory Affairs and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.
• Leverage internal and external forums to develop and share regulatory and drug development expertise around electronic submission structure and content.
• Communicate verbally and in writing to effectively influence within the GRA function and development teams.
• Guide and influence development teams and functions regarding internal and Agency life-cycle management processes and requirements.
• Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues.
• Proactive in approaching higher level colleagues in various organizations.

Business Expertise

• Subject matter expert (SME) responsible for the technical evaluation, implementation and documentation of CMC regulatory content, submission procedures/guidance, submission integration, and submission tracking.
• Comprehensive knowledge of evolving global agency publishing standards
• Comprehensive knowledge and skills related to the systems, processes and standards.
• Demonstrate expertise at planning CMC submissions.

Minimum Qualification Requirements:  

• Industry-related experience
• Knowledge of drug development process
• Demonstrated ability to manage operational requirements in a regulated environment
• Demonstrated written, spoken, and presentation communication
• Demonstrated negotiation and influence skills
• Demonstrated attention to detail
• Demonstrated ability to effectively prioritize and manage competing priorities and responsibilities
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
• Education: Combination of industry/regulatory business and/or technical knowledge and skills developed through education and experience.