Submission Specialist

Overview of Role

The Submission Specialist will support the Global Regulatory Affairs team for planning and organising submissions worldwide, with emphasis on US & EU submissions. This position will be reporting to the Submission Manager in Regulatory Operations (Reg. Ops.) while supporting the Global Regulatory Affairs (GRA) teams, by conducting and facilitating cross-functional kick-off meetings, liaising with internal and external stakeholders to drive filing teams forward through planning, coordinating, participating, and facilitating filing team meetings to ensure health authority requirements are met, documents finalised/approved and delivered to publishers on time to meet project and health authority timelines. The positions available with one staff working each of CET -6 (US EST), CET, and CET+6. Preference for location in (Bangalore) India.

Scope and responsibility

This position is a non-project-facing position supporting the Global Regulatory Affairs. This means that the team members won’t be assigned to a specific product but will instead, support the entire portfolio of products from early development through life cycle maintenance.

• Accountable for global regulatory submissions’ planning, acts as a point of contact (SPOC) for assigned projects for GRA and its stakeholders inside and outside Alvotech
• Creates and manages the Submission Content Plans (SCP), timelines and responsibility matrices through cross-functional discussions, and tracks submission deliverables to maintain the target filing date
• Ensures documents are compliant with Alvotech standards, ICH, and other guidelines for incorporation into eCTD submissions, using Veeva Vault RIM (SCP) functionality
• Acts as Subject Matter Expert (SME) for specific Reg. Ops tasks, such as building electronic submissions using Veeva Vault SCP and using validated processes and adhering to SOPs and Working Instruction documents
• Proactively shares best practice within the department and cross-functionally, identifies and communicates opportunities for departmental enhancements and efficiencies
• Quality Management: Follow regulations and company policies, and complies with all Alvotech Standard Operating Procedures
• Support additional regulatory responsibilities and tasks as agreed with management on ad-hoc basis and as required for business need
• Ability to present and actively communicate electronic submission requirements and processes and champion change, both within Global Regulatory Affairs and with key stakeholder groups in R&D
• Demonstrates Alvotech Values, ensures an efficient and transparent working environment within GRA
• Responsible for personal Continuous Professional Development to maintain up-to-date knowledge of new Regulatory requirements as well as technical developments relevant to own area of expertise and proactively share knowledge for the benefit of others

• Coordinates submission documents through review cycles and provides guidance to cross-functional groups on uploading submission documents to the RIM system.

Job requirements:

• Bachelor’s degree with 4 years or 8 years experience in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent
• Project management skills and ability to oversee and prioritize multiple activities across sites for multiple customers.
• Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
• Highly experienced in Microsoft Project, Vault RIM with emphasis on Submission Content Plan functionality, Extedo eCTDManager publishing tool experience is preferable. Strong attention to details, organisation, and time management skills. Strong sense of urgency, able to prioritize effectively such that key issues or emerging high priority matters are handled in a timely and effective manner.
• Demonstrates a continuous improvement mindset, identifying and recommending opportunities to streamline or improve processes
• Good judgment and decision-making skills, strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel), Adobe Acrobat & Toolbox, other relevant publishing and document management systems/software
• Ability to work in a matrix, teams, and diverse cultures is essential
• Fluency in English is essential, other languages are beneficial
• Ability to work outside of core business hours to achieve priorities as required
• Demonstrates the ability to independently solve problems that arise within job responsibilities and expectations of this role
• Effectively communicates situations both verbally and in writing with an appropriate sense of urgency
• Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures

About the Department/Company

The mission of Global Regulatory Affairs is building bridges between science and worldwide regulatory authorities to deliver affordable biosimilar medicines. Every team member has the goals of providing best-in-class regulatory guidance and advice, de-risking through sound but innovative regulatory strategy, and submitting quality regulatory documents in support of product development, licensure, and continued maintenance on the market.