Regulatory Affairs CMC Director (Marketed Product Optimization)
- East Hanover, New Jersey, United States
- Closing date
- Feb 10, 2023
- Other, Legal/Regulatory Affairs
- Position Type
- Full Time
- Job Type
- Organization Type
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, there is more we can do to help improve and extend people’s lives.
In Global Regulatory Affairs CMC, our work starts when a compound goes into clinical trials. Novartis has a unique and promising portfolio. All of these innovative projects are aimed at making a difference in patients’ lives and we need your help.
As a senior member of our Global Regulatory Affairs CMC team, your role would be to establish and drive global CMC regulatory strategic and operational direction and documentation for complex projects and products covering development, registration and approval/post approval activities.
Your Responsibilities include but are not limited to:
• Formulate, lead and drive global CMC regulatory strategy across all therapeutic areas and technology platforms, support projects/products drawing on extensive regulatory expertise with a focus on innovation, improving the business benefit equitable with regulatory risks and compliance
• Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions
• Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
• Author and/or review high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
• Represent Global Regulatory CMC on cross-functional project teams and maintain collaborative partnerships with stakeholders
• Initiate and lead Health Authority interactions and negotiations including more complex interactions; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Establish and maintain a single point of contact with FDA
• Act as a role model, providing strategic advice within and outside of RA CMC, driving continuous improvement and building the talent within the team through coaching and mentoring
Diversity & Inclusion / EEO
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.
What You’ll Bring to the Role:
• Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; advanced degree desired
• Minimum 10 years regulatory experience preferred and/or pharmaceutical industry experience
• Experience with mRNA/siRNA technology platforms is a plus
• Extensive knowledge/experience in regulatory submission and approval processes and ability to solve complex CMC regulatory issues and requirements
• Proven ability to critically evaluate data from a broad range of scientific subject areas
• Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects
• Demonstrated ability for innovative and big picture thinking
• Strong planning, negotiation, organizational and interpersonal skills
• Excellent written/spoken communication, and negotiation skills
Why Consider Novartis?
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 surrounded by people who share your determination to tackle the world’s toughest medical challenges. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to take smart risks.
We are Novartis. Join us and help us reimagine medicine.
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.
The pay range for this position at commencement of employment is expected to be between $183,200 and $274,800/year; however, while salary ranges are effective from 1/1/22 through 12/31/22, 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.
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.
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, join the Novartis Network here: https://talentnetwork.novartis.com/network
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
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