What are the responsibilities and job description for the Global Regulatory Submission Manager position at Novartis?
1,800 associates. 85 countries. 1 goal. At Novartis, we are dedicated to discovering and developing new treatments for diseases including cancer, heart disease, and neurological conditions—and delivering them at a scale to reach as many patients as possible. Novartis has a unique and promising portfolio with approximately 70 projects as potential NMEs in development, 52 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. And you could be at the center of it all in Regulatory Affairs (RA), where your voice, experience, and quality mindset can truly make a difference in drug development at Novartis. Read on to learn about the role available in RA. We hope you will consider joining our global RA family.
A position in Global Drug Development Regulatory Affairs Operations responsible for handling the delivery of cross functional submission documentation, being responsible for publishing activities and dispatch of compliant, worldwide regulatory submissions in support of Novartis global product portfolios.
Your Responsibilities include, but are not limited to:
A position in Global Drug Development Regulatory Affairs Operations responsible for handling the delivery of cross functional submission documentation, being responsible for publishing activities and dispatch of compliant, worldwide regulatory submissions in support of Novartis global product portfolios.
Your Responsibilities include, but are not limited to:
- Handles multiple and simultaneous global regulatory submission projects in eCTD and non-eCTD format [e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA AtoQ, Compliance submissions, etc.]
- Drives cross-functional teams focused on the planning, compilation and dispatch of worldwide regulatory submissions, anticipating technical obstacles and developing solutions
- Provides guidance to project teams related to worldwide HA submission structure at/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows
- Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and coordinates internal review and approvals
- Partners with cross functional groups across the organization and contributes to operational activities and ongoing initiatives
- Effectively troubleshoots technical/quality issues relating to compilation, validation and dispatch of global submission outputs
- Assesses publishing resource and support needs and develops/implements solutions to create efficiencies
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Minimum requirements
What you bring to the role:
Why Novartis?
736 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com or call 1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities
- BS in Life Sciences or a relevant discipline with at least 5 years of professional work experience. Masters degree preferred.
- 3-5 years of Regulatory Affairs or Regulatory submission related experience.
- Experience with global regulatory submission formats, including familiarity with submission publishing activities
- Familiarity with the drug development process
- Effective interpersonal skills, strong written and oral communication and presentation skills
- Proven project management, organizational and time management skills to manage multiple ongoing projects simultaneously
- Familiarity with global Health Authority regulations/guidances eg., FDA regulations, ICH and EMA guidelines/directives
- Works independently and with minimal supervision
- Proficiency with computer programs/systems (MS office, etc.) with proven ability to learn new systems quickly
Why Novartis?
736 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com or call 1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities
Division
Global Drug Development
Business Unit
REG AFFAIRS GDD
Country
USA
Work Location
East Hanover, NJ
Company/Legal Entity
Novartis Pharmaceuticals
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
Salary : $112,800 - $169,200