Regulatory Affairs CMC Associate Director/Director (Global Health)
576! That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients' lives and we need your help. As a 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 projects and products covering development, registration and approval/post approval activities.
\*\* Role will be filled at level commensurate with experience\*\*
Your Responsibilities include but are not limited to:
\* Formulate, lead and drive global CMC regulatory strategy for Global Health projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the business benefit balanced 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: setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Establish and maintain a single point of contact with FDA
\* Provide strategic advice and direction within the department and cross-functionally through specialized assignments
Commitment to Diversity & Inclusion:
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
For Associate Director: Minimum 8 years regulatory experience preferred and/or pharmaceutical industry experience
For Director: Minimum 10 years regulatory experience preferred and/or pharmaceutical industry experience
\* Substantial knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements
\* Proven ability to critically evaluate data from a broad range of scientific subject areas.
\* Proven 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?
769 million. That's how many lives our products touched in 2020. 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 embraces diversity, equal opportunity and inclusion. 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.
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:
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to firstname.lastname@example.org 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.
Global Drug Development
REG AFFAIRS GDD
East Hanover, NJ
Research & Development
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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Novartis Group Companies
Our mission is to care and cure. We want to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life.
Novartis has five business segments and is supported by our global research organization, the Novartis Institutes for BioMedical Research (NIBR). These segments are strategically aligned to bring innovative, high-quality and affordable medicines and therapies to patients around the world.
We strive to provide our associates with the safest possible workplace and to promote their health and well-being. We are an integral part of the communities that host our operations. We pay living wages worldwide, contributing to the stability and prosperity of these communities.
At Novartis, we often achieve success through close collaboration with partners who share a common vision and complementary strengths.