Regulatory Affairs Coordinator

1.066.824. That’s the number of patients we reached in 2021. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. Did you ever imagine how many lives could be touched by your daily work?
- The people we serve need you to achieve the extraordinary. That´s why at Novartis we empower you to bring your best self; we value your diversity of thought and trust your ability to make things happen.-
**Your responsibilities**:
Your responsibilities include, but are not limited to:
- Support to product registration activities for new products and indications, in accordance with registration Plans and projects.
- Review and set a Life Cycle Management Plan in collaboration with local and regional functions.
- Artworks and promotional materials management.
- Maintain product licenses in terms of Life Cycle management CMC/variations/ CDS/safety update according to local regulations/ global guidelines and in regulatory compliance.
- Communication and close coordination with GCQ ( quality), GDQ, Supply, Commercial and other internal areas to assure implementation of CMC changes, SKU´s or transfers avoiding commercial issues or shortage of products. Support Business Development and License initiatives
- Translates regulatory intelligence into tangible regulatory strategy for products in charge.
- Timely communication of any relevant regulatory topic in scope.
- Lead and provide regulatory support during Change control & operational meetings. Perform and comply with all assigned training -100%.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**Minimum requirements**

**What you’ll bring to the role**:

- Degree in Pharmaceutical Chemistry is desired.
- 2-3 years of experience within the pharmaceutical industry.
- Knowledge of local regulation, ICH, FDA, and EMA
- Experience in local and international regulations
- English at a fluent level.

**You’ll receive**:
Competitive salary, annual bonus, life insurance, home office policy, flexible working arrangements, birthday day-off, maternity and paternity leave, subsidized dining facilities, health and dental insurance, employee recognition scheme, Gympass, and virtual self-development tools.**Why consider Novartis?**

21.000. That’s how many people Novartis hires globally every year, 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 at Novartis**

**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding,inclusive work environment and diverse team’s representative of the patients and communities we serve.-
**Division**
- Global Drug Development

**Business Unit**
- REG AFFAIRS GDD

**Country**
- Colombia

**Work Location**
- Bogotá D.C

**Company/Legal Entity**
- NOV COL

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- Yes