This position is responsible for supporting EMEA (Europe, Middle East, Africa) regional lead of SOM by managing the preparation and submission of all CTAs / MAAs and lifecycle management of these submissions in both paper and electronic format to Health Authorities in the EMEA region.
Experience with submitting applications / dossiers to US, Canada, and Asia Pacific countries / regions in eCTD, NeeS and paper format is preferred.
This position will actively participate in the development of streamlined submission processes, internal quality checks, and metrics reporting based on industry best practices.
A key success factor is the ability to develop and maintain cross functional relationships to enable high quality output, timely and compliant submissions to Health Authorities within EMEA.
This position will oversee the daily activities (e.g. document processes, submission publishing) of the EMEA Publishing and Technical Editing function, as applicable.
Overview of Essential Duties & Responsibilities : Strong experience with submission requirements and guidelines for all submission types, both paper and electronic.
Hands on experience with regulatory submission processes. Act as lead publisher for EMEA applications; communicate resource constraints to management, deliver on submission timelines, track and report submission progress, organize appropriate levels of technical support, escalate and / or resolve technical issues, dispatch submission in the required format(s) within EMEA and expanding to other regions outside EMEA.
This position can be responsible for report level publishing, as required. Responsible for submission dossier management tasks including QC for EMEA major applications and lifecycle / routine submissions.
This includes all document management tasks (file transfer, storage and tracking), creation and QC of all navigation (e.
g. hyperlinks, bookmarks, validation) to ensure compliance for Health Authority acceptance. Support Regulatory Affairs in delivering high quality and consistent lifecycle / routine Health Authority submissions, with strong operational knowledge for those submission types.
Support Regulatory / Reg Ops with managing submission documentation and internal review processes for regulatory dossiers.
Represent the Reg Ops team on Global Filing teams and / or Regulatory Projects teams to provide status updates and input related to key submission deliverables (e.
g. impact to submission timelines). Responsible for communicating resource needs based on short and long-term filing plans and advise management of resource implications.
Build a strong partnership and communication vehicles with internal teams to achieve project expectations, mitigating and communicating potential project risks.
Develop and maintain effective relationships with Regulatory / Reg Ops peers, and external Consultants / Vendors to optimize outcomes.
6+ years of direct Regulatory Affairs / Regulatory Operations experience. Preferred candidates will have experience working across two or more major geographic areas.
Significant experience within a Regulatory / Regulatory Operations environment including hands on eCTD experience and broad industry standard systems knowledge.
Prior management experience. Working knowledge of business software, including MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
Experience in the preparation and submission of documents using regulatory / document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required Ability to think strategically with a focus on process improvement and optimization.
Excellent verbal and written skills and attention to detail as well as time management and prioritization skills. Demonstrated ability to balance multiple projects to achieve goals and meet deadlines and customers’ expectations.
Relevant experience includes project coordination / management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations.
Working knowledge of regulatory guidelines and regulations. Organized with systematic approach to prioritization. Process orientated to achieve the business objective.
Ability to learn new technologies and processes quickly. Extensive experience with INDs / CTAs, NDAs / BLAs / MAAs, lifecycle management, leading and managing regulatory operations teams, developing, and implementing regulatory operations strategies with a proven track record of accomplishments.
Strong business acumen and ability to make sound decisions that contribute positively to the business. Ability to effectively operate independently and as part of a global team.
Strong strategic skills including creativity and effectiveness in identifying and addressing major challenges and the ability to balance short-term needs with long-term vision.
Proven ability to deliver on goals within a cross-functional team / partnership environment with a high level of professionalism.
Ability to work flexible business hours to support submissions within a global Regulatory Operations team environment. Primary Job Requirements : Extensive experience with regulatory submission processes, documents, and requirements, such as INDs, clinical trial applications, Therapeutic Biologics Applications (BLA).
Excellent interpersonal skills with the ability to build strong relationships across multiple functions and organizations.
Ability to work independently and with the flexibility to handle workflow in a fast-paced environment. Proven excellence in operational strategy.
Ability to interpret, communicate, and present regulatory information in a clear and concise manner. Demonstrated ability to influence peers and external colleagues proactively and effectively across all levels of management.
Proven negotiation skills. Self-starter, independent and a practical thinker, strong and passionate team leader. Excellent verbal, written communications, and meeting presentation skills.
Competencies : Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning / Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time.
Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit, Shares expertise with others.
Adaptability Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation.
Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Gathers and analyzes information skillfully Project Management - Communicates changes and progress; Completes projects on time and budget.
NO AGENCY ASSISTANCE REQUIRED