Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. We were founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that meet real needs. More than a century later, we are passionate about building on this precedent in our continued pursuit to make life better for individuals, communities, and the world around us.
Post : Associate Manager-CMC Rdoc
Responsibilities
Regulatory & Drug Development Expertise
• Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenace submissions. This includes defining key requirements for individual markets by RRIC and affiliate query, establishing and monitoring content due dates, and developing the integrated egulatory strategy to ensure timely submissions.
• Review Regulatory Strategies across molecule and identify opportunities to simplify and streamline submissions for markets and/.or regions.
• Interpret and implement global agency regulations, guidances and regulatory precedence into GRA-CMC 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 expertise in CMC RA submission processes, electronic submission regulations and guidance regarding technical content and structure requirements to CMC development teams regarding global CTAs and registration dossiers.
• Provide formal CMC team training on CMC RA submission processes, timeline expectations and Leo/Regulus/RAPT tool usage and, as needed, 1:1 training / guidance of CMC authors.
• 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.
• For Development projects, serve as the GRA-CMC RA operational lead for global CTA and registration planning and execution, including Critical chain status updates. Own execution of the right to operate routine compliance submissions, such as DSUR and IND Annual Report submission processes.
• Own the creation of Clinical Trial Commitment Documents (CTCDs), 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 (Q&A database, Planning and Tracking Tools, and RAPT), preparing periodic or special request trend reports to enable CMC staff to identify and address global agency review 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 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
• Partner with the GRA-CMC RA Scientist to plan, facilitate and document internal regulatory draft review meetings, and/or submission integration/planning sessions.
• Lead the communication and transfer of registration submission commitments by country between GRA-CMC RA and Site Regulatory Affairs groups in accordance with CMC Regulatory Transition process.
• Create an environment within the GRA 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 continue to develop and share regulatory and drug development expertise around electronic submission structure and content.
• 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
• Proactive in approaching higher level colleagues (i.e. Regulatory Scientist, MSP authors, FING data steward, Molecule Planner, CT Demand Forecaster, etc.) in different organizations to resolve misalignment issues between Material Specification Package (MSP) and the CT submission.
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Business Expertise
• Subject matter expert (SME) responsible for the technical evaluation, 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 (Leo/Regulus,eCTDXpress, RAPT, and RRIC),.
• Demonstrated expertise at planning CMC submissions, including RRIC database usage and affiliate interaction
• Manage Leo/Regulus access for CMC organization and management of CMC submission template process.
Candidate Profile
Bachelor’s Degree. Scientific or health sciences discipline preferred (e.g. pharmacy, nursing, chemistry or related scientific discipline) could enable further long-term advancement opportunities
Basic Qualifications
• 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
• Education: Combination of industry/regulatory business and/or technical knowledge and skills developed through education and past experience.
Additional Information:
Qualification : B.Pharm
Location : Bangalore
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 03-Jul-2018
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