We also focus on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family friendly work flexibility to facilitate your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.
Your responsibilities include, but are not limited to:
- Electronically preparing, publishing, quality reviews, validation (using eCTD validator tool), and dispatch activities related to regulatory submissions (e.g., INDs, BLAs/NDAs, MAAs, HA AtoQs, Global Labeling, Annual Reports, etc.)
- Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS and Paper) in adherence to assigned timelines and in compliance with worldwide HA requirements (US, EU, LACan, Most of World)
- Partners with Operations Submission Managers and a publishing team located in 3 regions (e.g., US, EU and India) and actively functions in a global capacity
- Liaises /collaborates with cross functional team members and document authors (e.g., Project Management, Clinical, Nonclinical, CMC, Safety and Quality functions) to achieve timely dispatch of high quality submissions
- Follow and actively apply internal work practices and guidelines
- Support implementation of new technologies, tools and processes as well as contribute to ongoing initiatives and training efforts
- Identify process or technical issues and propose solutions relating to timing, quality, compliance and resources
- Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team
EEO Statement
Minimum requirements
- Education: BS in life sciences or a relevant field with min 3 years of professional work experience
- 3-5 years submission publishing experience in Pharma or related industry
- Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria
- Effective interpersonal skills, strong written and verbal communication and presentation skills
- Project management and time management skills to handle multiple ongoing projects simultaneously
- Working knowledge of regulatory affairs
- Works independently and with minimal supervision
- Demonstrated team player who works well under pressure, works well within a culturally diverse environment and someone who actively applies and demonstrates a business code of conduct
- Proficiency with computer programs/systems (MS office, etc.) with proven ability to learn new systems quickly
- Analytical skills and problem solving skills
- Ability to coordinate and work effectively with cross-functional teams.
Why Consider Novartis
736 million. That’s how many lives our products touched in 2022. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do 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: [email protected] 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 $92,800 and $139,200/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 hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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