Location: Plainsboro, NJ
Company: Novo Nordisk
and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life.
We’re changing lives for a living. Are you ready to make a difference? The Position The Associate Manager, Regulatory Operations - Submissions supports the development of submission plans created for regulatory submissions. This individual collaborates cross-functionally and applies project management skills and knowledge of drug development and how it relates to regulatory dossier
practices and requirements to manage the execution of submissions. This individual also supports the systems and processes by which regulatory documentation is created, approved, submitted, maintained for use, and made readily searchable and accessible.
The Associate Manager, Regulatory Operations Submissions is also responsible for tracking the progress of all components of a regulatory submission dossier. This individual acts as Subject Matter Expert (SME) for producing a dossier that is compliant with the required format (i. e. e CTD, paper, etc. ) and that is in alignment with the submission strategy. The individual works cross-functionally with internal departments on Regulatory
Affairs related issues. Relationships This person will report to management in Regulatory Operations and Innovation.
Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments as needed. Essential Functions Participates on cross-functional teams focused on the planning and execution of regulatory submissions. This includes anticipating regulatory submission obstacles, identifying emerging issues and proactively developing solutions Participates in FDA and HC submission planning meetings to ensure clear communication of the project plan, actions items, risks, and decisions to the team With little management oversight, independently manage multiple regulatory submission projects, including the development of submission content plans Ensures that all regulatory content and information is appropriately tracked, archived, searchable and accessible Enters and tracks project and submission data in Regulatory Information Management system (Vault RIM) Works directly with Regulatory Project Mangers to develop submission content project plans Works directly with publishing colleagues, to ensure an accurate and quality assembly of submission dossiers With little management oversight, participates locally and globally in initiatives focused on the improvement of regulatory submission management processes and tools (Veeva Vaults RIM, Registrations, Publishing and Ad Promo Mats).
This includes developing and contributing to new regulatory processes and providing training support as appropriate With little management oversight, independently and actively manage and/or participate in projects related to system enhancements, product transfers and/or other Regulatory needs With little management oversight, may contribute to the development of SOPs, Work Instructions (WIs) and training materials required to support regulatory submission-related activities.
Updates internal processes to ensure compliance with health authority requirements and expectations Physical Requirements 0-10% overnight travel required. Qualifications A Bachelor 's Degree Required; relevant and equivalent experience may be substituted for degree A minimum of 6 years progressively responsible, relevant experience , with a concentration in document management and e CTD publishing Demonstrated ability to work cross-functionally to develop project plans; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status Demonstrated ability and knowledge to define, and lead the implementation of, process/system improvements related to regulatory submissions (Veeva Vaults RIM, Registrations, Publishing and Ad Promo Mats) May Provide guidance and training to less experienced professionals or support staff.
Demonstrates leadership qualities; may act as project leader in the development and implementation of processes and programs. May be responsible for managing projects, processes, or programs with own manager oversight Full knowledge of FDA and Health Canada e CTD submissions lifecycle management and associated guidance’s/specifications/regulations Proficiency with Microsoft Office, Veeva Vault(s), CSC Toolbox Excellent verbal and written communication and skills Ability to work independently and collaboratively, as required, in a fast-paced, team environment consisting of local and global team members Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, interaction, gender identity, interactionual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at -xyz X. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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Management & Executive Jobs refer to positions within an organization where individuals are tasked with making strategic decisions, overseeing operations, and leading teams towards achieving business goals. These roles typically include titles such as manager, director, vice president, and CEO, and are characterized by their high level of responsibility, authority, and often, a requirement for extensive experience and leadership skills. Executives set the vision for the company, while managers implement strategies and policies to drive success. These jobs often involve complex problem-solving, strong communication abilities, and the capacity to influence and motivate others.
Management & Executive Jobs refer to high-level positions within an organization that involve overseeing operations, making strategic decisions, and leading teams towards achieving business objectives. Individuals in these roles typically have significant experience and expertise in their respective fields. They are responsible for setting goals, developing policies, and ensuring the effective management of resources. Executive roles often include titles such as CEO, CFO, COO, and department heads, among others. Characteristically, these jobs demand strong leadership skills, excellent communication abilities, and a capacity to think critically and solve complex problems.
Management & Executive Jobs refer to positions within an organization where individuals are tasked with making strategic decisions, overseeing operations, and leading teams towards achieving business goals. These roles typically include titles such as manager, director, vice president, and CEO, and are characterized by their high level of responsibility, authority, and often, a requirement for extensive experience and leadership skills. Executives set the vision for the company, while managers implement strategies and policies to drive success. These jobs often involve complex problem-solving, strong communication abilities, and the capacity to influence and motivate others.
