What are the responsibilities and job description for the Specialist - Regulatory Operations Submissions position at BioSpace?
About The Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy 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 Specialist, Regulatory Operations - Submissions supports the development of submission plans created for regulatory submissions. This individual will be responsible for supporting the preparation, delivery, archiving and tracking of regulatory submissions to FDA and Health Canada. This individual also supports senior staff with required systems and process maintenance. Responsible for supporting the preparation, delivery, archiving and tracking of regulatory submissions to FDA and Health Canada.
Relationships
Reports to Management in Regulatory Operations and works cross-functionally with internal departments on Regulatory Affairs related issues.
Essential Functions
With direction from management 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.
With direction from management 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 direction from management, manages 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).
With direction from management works directly with Regulatory Project Managers to develop submission content project plans.
With direction from management works with publishing colleagues, to ensure an accurate and quality assembly of submission dossiers.
With direction from management participates locally and globally in initiatives focused on the improvement of regulatory submission management processes and tools (Veeva Vaults RIM, Registrations, Publishing and AdPromoMats). This includes developing and contributing to new regulatory processes and providing training support as appropriate.
With direction from management contributes 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 requirements and expectations.
Qualifications
A Bachelor's Degree Required; relevant experience may be substituted for degree, when appropriate
A minimum of 4 years progressively responsible, relevant experience, with a concentration in document management and eCTD 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 AdPromoMats).
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 eCTD 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.
The base compensation range for this position is $81,010 to $145,820. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy 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 Specialist, Regulatory Operations - Submissions supports the development of submission plans created for regulatory submissions. This individual will be responsible for supporting the preparation, delivery, archiving and tracking of regulatory submissions to FDA and Health Canada. This individual also supports senior staff with required systems and process maintenance. Responsible for supporting the preparation, delivery, archiving and tracking of regulatory submissions to FDA and Health Canada.
Relationships
Reports to Management in Regulatory Operations and works cross-functionally with internal departments on Regulatory Affairs related issues.
Essential Functions
With direction from management 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.
With direction from management 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 direction from management, manages 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).
With direction from management works directly with Regulatory Project Managers to develop submission content project plans.
With direction from management works with publishing colleagues, to ensure an accurate and quality assembly of submission dossiers.
With direction from management participates locally and globally in initiatives focused on the improvement of regulatory submission management processes and tools (Veeva Vaults RIM, Registrations, Publishing and AdPromoMats). This includes developing and contributing to new regulatory processes and providing training support as appropriate.
With direction from management contributes 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 requirements and expectations.
Qualifications
A Bachelor's Degree Required; relevant experience may be substituted for degree, when appropriate
A minimum of 4 years progressively responsible, relevant experience, with a concentration in document management and eCTD 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 AdPromoMats).
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 eCTD 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.
The base compensation range for this position is $81,010 to $145,820. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Salary : $81,010 - $145,820
