Ra Cmc Director-policy and Intelligence
Vor 3 Tagen
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 maintain the oversight of the global regulatory CMC intelligence and policy activities across modalities, develop Novartis positions and provide strategic direction, represent Novartis in external groups and associations, positively influence the internal and external regulatory environment, evaluate the impact and opportunities of new trends/guidelines for the Novartis enterprise and provide actionable guidance to the organization.Your Responsibilities include but are not limited to:
- Monitor, interpret, analyze impact and opportunities and communicate existing and new global regulatory expectations and trends to facilitate decision making and development of strategies in alignment with business objectives.
- Develop Novartis positions and strategies and advise on emerging regulatory trends to ensure regulatory CMC strategies and submissions reflect the most contemporary expectations globally.
- Coordinate commenting of regulatory drafts for public comment and monitor evaluation and implementation of final CMC regulation or guidelines.
- Represent Novartis in external working groups, trade associations and other stakeholder groups.
- Understand and influence the regulatory landscape in areas of interest for Novartis. Seek interaction with regulators through speaking opportunities, trade associations, publications, and formal and informal meetings.
- Provide strategic advice on challenging or new regulatory CMC topics, support preparation of Health Authority meetings on emerging topics.
- Develop and deliver training and lessons learned on emerging topics.
- Act as a role model, providing strategic advice within and outside of Regulatory CMC, driving continuous improvement through mentoring.
**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._
**Minimum requirements**
- What You’ll Bring To The Role- Command of the drug development process, pharmaceutical business, and regulatory landscape.
- Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams.
- Ability to enable teams to think strategically, creatively, and proactively.
- Strong planning, negotiation, organizational and interpersonal skills.
- Excellent written/spoken communication, and negotiation skills.
- 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 in technical space
- Deep global regulatory CMC knowledge of small and large molecules including new modalities
- Experience in interactions with Health Authorities and trade associations
- Extensive knowledge/experience in regulatory submission and approval processes and ability to solve complex CMC regulatory issues.
- Proven ability to critically evaluate information from a broad range of scientific disciplines.
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.
**Division**
- Global Drug Development
**Business Unit**
- REG AFFAIRS GDD
**Country**
- Switzerland
**Work Location**
- Basel
**Company/Legal Entity**
- Novartis Pharma AG
**Alternative Country 1**
- USA
**Functional Area**
- Research & Development
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No
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