Lilly CMC Regulatory Associate Vacancy – Chemistry & Pharma
The GRA-CRR-CMC Regulatory Associate/Author leads, in partnership with the GRA-CMC RA Scientists, the various aspects of global marketing authorization submission management processes. The Regulatory Associate/Author also partners with GRA-CMC Scientists to help create and manage Leo/Regulus submission content, and to provide guidance on structure and content placement within CTD registration submissions, and to provide assistance with submission related Ministry of Health responses or Lilly affiliate questions.
Job Title: Associate/ Senior Associate CMC Regulatory
- The Regulatory Associate/Author works within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working knowledge of internal procedures, guidances and regulatory precedence.
- The Regulatory Associate/Author will triage and manage the communications between our Lilly Affiliates, GRA-CMC Scientists, Specialists, and the Quality/ Reg Representatives The Regulatory Associate/Author utilizes GRA-CMC submission process expertise and their expertise with – Information Technology tools to develop project management expectations across projects. Based on implementation and supply chain needs within manufacturing, the GRACMC Regulatory Associate will be responsible for routine communication of submission tracking requirements to both GRACMC Scientists and internal customers.
- The scope of work includes global regulatory requirement assessment and strategy development, coordination of submissions with the submission specialists, and project management for marketed product support.
Regulatory & Drug Development Expertise
- Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products. This includes defining and delivering key requirements for individual countries, establishing and monitoring content due date, and developing the integrated strategy to ensure timely submissions.
- Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions. This includes defining key requirements for individual markets, establishing and monitoring content due dates, and developing the integrated regulatory strategy to ensure timely submissions.
- Review Regulatory Strategies across molecule and identify opportunities to simplify and streamline submissions for markets and/or regions.
- Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements by utilizing CMC RA Scientist for mentoring and content review
- Responsible for triage of Lilly affiliate inquires and requests and when necessary consults with CMC RA Scientist for guidance. Partners with the CMC RA Scientist and in some cases leads the effort to manage development of responses to questions with the CMC RA Scientist.
- Implement and in some cases interpret global regulations andguidances and look to regulatory precedence into GRACMC RA submission processes and publishing standards to ensure final document content and structure are compliant with local regulatory requirements. Partner with Lilly affiliate regulatory staff, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.
- Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers.
Own the submission management process at the molecule/project submission level to ensure all required electronic records are timely, complete, and accurate. Track affiliate submission and market approvals.
- Serve as the GRA-CMC RA operational lead for global IND/CTA, MAA, and registration planning and execution, including Critical chain status updates. Own execution of the right to operate routine compliance submissions, such as DSUR ,PSUR, and IND Annual Report submission processes.
- Own the creation of R.DOCs, Regulatory Commitment Verification Forms (RCVFs), and the Regulatory Commtiment Matrix (COMTRIX) to enable Lilly Quality to review and release clinical and marketed materials.
- Manages CMC databases and/or information tools , preparing periodic or special request trend reports to enable CMC staff to identify and address global agency review trends.
- Accountable for interpreting and responsible for proactively communicating with regulatory representatives intercontinental market, approval, and project status information in appropriate tracking tools and accurately identify post-approval commitments in global markets. 2. 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 across GRA PRD, and/or Manfucaturing and Quality functions.
- Develop collegial and mutually productive relationships across Lilly’s components, partner companies, Lilly Affiliates and GRA submission centers (e.g. CRR & ELERT) that enable team environment of developing quality submissions in a timely fashion
- Lead the communication and transfer of registration submission commitments by country between GRA-CMC RA and Site Regulatory Affairs groups in accordance with the CMC Regulatory Transition process.
- Create an environment within the GRA and across CMC development teams that encourage open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues. Consult with department regulatory representatives and country affiliates to share best practices and move towards more efficient and effective business processes.
- Leverage internal forums to continue to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements.
- Communicates verbally and in writing to effectively influence within work group/function and with development team
- 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 across multiple functions and geographies · Identifies and escalates CMC regulatory issues impacting product submissions across geographies.
Business Expertise
· Subject matter expert (SME) responsible for, implementation and documentation of CMC regulatory strategy, submission procedures/guidances, submission integration, and submission tracking.
· Comprehensive knowledge of ICH CTD and evolving global agency publishing standards
· Comprehensive knowledge and skills related to Lilly systems, processes and standards
· Demonstrated expertise at planning CMC submissions, including appropriate knowledge management tools and affiliate interaction
Minimum Qualification Requirements:
Bachelor’s Degree. Scientific or health sciences discipline (e.g. pharmacy, chemistry or related scientific discipline) could enable further long-term advancement opportunities or equivalent demonstrated industry/regulatory business and/or technical knowledge and skills developed through education and past experience
Other Information/Additional Preferences:
- Industry-related experience § Knowledge of Agency submission procedures and practices. Knowledge / awareness of emerging submission electronic standards.
- Knowledge of drug development process, Lilly regulatory/business strategies and plans
- Demonstrated ability to operate and manage operational requirements in a regulated environment
- Demonstrated written, spoken and presentation communication
- Demonstrated negotiation and influence skills § Demonstrated attention to detail
- Demonstrated expertise and skill set for publishing complex CMC submissions, including global CTA and/or CTD submissions using Leo and eCTDXpress publishing systems.
- Demonstrated ability to effectively prioritize and manage competing priorities and responsibilities
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
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