What are the responsibilities and job description for the Associate Manager - Regulatory Affairs - Labeling position at BioSpace?
About
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 health-care-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
We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects guided by company content of labeling, FDA Patient Labeling Resources, FDA Label Negotiations and Industry trends. This requires labeling verification to include the review across the product family of physician and patient leaflets, carton and container labels as well as device labels. The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling Projects and Planning Coordinators (LPPC), Graphic Designers, Marketing and Supply Chain.
Relationships
Reports to labeling management in Regulatory Operations (RO), engaging with key company personnel within Novo Nordisk Inc., US (NNI) and Novo Nordisk A/S (NN) to drive successful project outcomes for assigned projects. Develops and maintains positive working relationships with company stakeholders, fostering effective collaboration with Regulatory Affairs (RA), Supply Chain, and HQ colleagues to ensure labeling compliance and accomplish company goals.
Key Responsibilities
Label Development:
Represent RO Labeling during NNI - Local Labeling Committee (LLC) and HQ – Product Labeling Council meetings and communications, ensuring accurate reconciliation and incorporation of comments into draft labels in collaboration with responsible TA personnel
Drive the Final Printed Labeling review and approval process based on final approved labeling content from FDA, collaborating with TA, LPPC, and Graphic Designers to ensure successful on-time launch of product labeling per company launch readiness timelines
Ensures additional filing requirements are completed for approved content of labeling to include SPL drug Listing, FDA 2253s and Puerto Rico Registrations
Labeling Tools
Serve as a subject matter expert in all labeling tools (SPL, TVT, Veeva Vault, Esko, Acrobat, etc.) coordinating technical support needs with internal IT groups
Utilizing FDA portals and tools to include WebTrader, CDER NexGen, FURLS, SPL Help Desk, FDALabel, Drugs@FDA and coordinating with agencies to resolve any issues
Regulatory Support
Act as a resource for colleagues, providing guidance, training, and mentorship, while contributing to the development of new concepts, standards, and techniques in labeling operations
Participate in cross-functional teams locally and globally, demonstrating good judgment in troubleshooting to resolve problems of moderate scope and complexity
Competence in Lot Distribution Data Reports, CARES Act Distribution Reporting, SPL Blanket No Change Certification, FDA Establishment Registrations, FDA Annual Reports, FDA PBRER, Certificate of Pharmaceutical Products, and PRDOH Puerto Rico Registrations
Actively participate in industry meetings and conferences to stay abreast of regulatory developments and industry trends
Physical Requirements
0-10% overnight travel required.
Qualifications
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, 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.
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 health-care-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
We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects guided by company content of labeling, FDA Patient Labeling Resources, FDA Label Negotiations and Industry trends. This requires labeling verification to include the review across the product family of physician and patient leaflets, carton and container labels as well as device labels. The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling Projects and Planning Coordinators (LPPC), Graphic Designers, Marketing and Supply Chain.
Relationships
Reports to labeling management in Regulatory Operations (RO), engaging with key company personnel within Novo Nordisk Inc., US (NNI) and Novo Nordisk A/S (NN) to drive successful project outcomes for assigned projects. Develops and maintains positive working relationships with company stakeholders, fostering effective collaboration with Regulatory Affairs (RA), Supply Chain, and HQ colleagues to ensure labeling compliance and accomplish company goals.
Key Responsibilities
- Review and provide regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirements
- Identify labeling issues, troubleshoot, and communicate effectively with relevant stakeholders to ensure timely resolution
- Monitor, evaluate, and recommend improvements to labeling processes, quality, and system tools, in alignment with FDA regulations and industry best practices
Label Development:
Represent RO Labeling during NNI - Local Labeling Committee (LLC) and HQ – Product Labeling Council meetings and communications, ensuring accurate reconciliation and incorporation of comments into draft labels in collaboration with responsible TA personnel
Drive the Final Printed Labeling review and approval process based on final approved labeling content from FDA, collaborating with TA, LPPC, and Graphic Designers to ensure successful on-time launch of product labeling per company launch readiness timelines
Ensures additional filing requirements are completed for approved content of labeling to include SPL drug Listing, FDA 2253s and Puerto Rico Registrations
Labeling Tools
Serve as a subject matter expert in all labeling tools (SPL, TVT, Veeva Vault, Esko, Acrobat, etc.) coordinating technical support needs with internal IT groups
Utilizing FDA portals and tools to include WebTrader, CDER NexGen, FURLS, SPL Help Desk, FDALabel, Drugs@FDA and coordinating with agencies to resolve any issues
Regulatory Support
Act as a resource for colleagues, providing guidance, training, and mentorship, while contributing to the development of new concepts, standards, and techniques in labeling operations
Participate in cross-functional teams locally and globally, demonstrating good judgment in troubleshooting to resolve problems of moderate scope and complexity
Competence in Lot Distribution Data Reports, CARES Act Distribution Reporting, SPL Blanket No Change Certification, FDA Establishment Registrations, FDA Annual Reports, FDA PBRER, Certificate of Pharmaceutical Products, and PRDOH Puerto Rico Registrations
Actively participate in industry meetings and conferences to stay abreast of regulatory developments and industry trends
Physical Requirements
0-10% overnight travel required.
Qualifications
- A Bachelor’s degree required
- A Minimum 6 years of Regulatory experience required with a concentration in labeling development and maintenance
- Proficiency with 21 CFR Labeling, Physician Labeling Rule (PLR), Selected Requirements of Prescribing Information, FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, industry-standard labeling trends, DUNS, and FEI Registrations.
- An experienced professional having a wide range of experience and a complete understanding of Regulatory Labeling roles and responsibilities
- Demonstrates full knowledge of industry practices and standards related to labeling, product listings and establishment registrations
- Excellent communication, collaboration, and interpersonal skills to work effectively with cross-functional teams and key company personnel.
- Strong problem-solving abilities with a keen attention to detail and adherence to federal requirements and best practices.
- Proven ability to independently manage labeling processes, prioritize tasks, and drive successful outcomes.
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, 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.
