Regulatory Affairs Coordinator

hace 3 semanas


Bogota, Colombia Novartis A tiempo completo

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



  • Bogota, Colombia Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Other **Environmental Conditions** Office We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with...


  • Bogota, Colombia Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    Johnson & Johnson MedTech is one of three successful divisions of the world's leading Johnson & Johnson family of companies. We are making an important contribution to the successful treatment of a wide range of common and chronic diseases with innovative - often pioneering - medical technologies and products. Are you ready to take your regulatory affairs...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    At **Johnson & Johnson **, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than...


  • Bogota, Colombia Zimmer Biomet A tiempo completo

    **Requisition Number**: AMER28216 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission...

  • Intern Regulatory Affairs

    hace 3 semanas


    Bogota, Colombia Zimmer Biomet A tiempo completo

    **Requisition Number**: AMER29097 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: The Regulatory Affairs Department of ZB plays a critical role in ensuring that our products comply with all regulations and requirements established by regulatory authorities. This department is responsible for coordinating and managing all activities...

  • Intern Regulatory Affairs

    hace 3 semanas


    Bogota, Colombia Zimmer Biomet A tiempo completo

    -Requisition Number AMER29097 Employment Type Full-time Location Bogota **Job Summary**: - The Regulatory Affairs Department of ZB plays a critical role in ensuring that our products comply with all regulations and requirements established by regulatory authorities. This department is responsible for coordinating and managing all activities related to the...


  • Bogota, Colombia ARIAD A tiempo completo

    **REGULATORY AFFAIRS SPECIALIST**: Bogotá, Bogota D.C. **Job ID** R0117127 **Category** Research & Development **Subcategory** Research & Development **Business Unit** Global Portfolio Division **Job Type** Full time **Regulatory Affairs Specialist** **_ Versión Español_** **PROPOSITO DEL ROL** Este rol es responsable de apoyar el plan...


  • Bogota, Colombia Zimmer Biomet A tiempo completo

    At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...


  • Bogota, Colombia Takeda Pharmaceutical A tiempo completo

    **Regulatory Affairs Specialist** **_ Versión Español_** **PROPOSITO DEL ROL** Este rol es responsable de apoyar el plan estratégico del negocio para obtener autorizaciones de comercialización y variaciones, tanto para productos existentes como nuevos. Además, coordinará las actividades de Excelencia Regulatoria en Colombia asegurando el...


  • Bogota, Colombia Galderma A tiempo completo

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...


  • Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives** **A Day in the Life** Responsibilities may include the following and other duties may be assigned. - Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. - Leads or compiles all materials required in submissions, license...


  • Bogota, Colombia AbbVie A tiempo completo

    **Company Description** - Preparation of state-of-the-art regulatory dossiers, according to product regulatory strategy previously aligned. - T end to look always for a first pass approval from the health authorities. In case any inquire, assure a timely and accurate response as well as look for learning, avoiding same inquiries in future regulatory...


  • Bogota, Colombia Novasyte A tiempo completo

    POSITION TITLE: Regulatory Affairs Specialist REPORTS TO: Manager, Regulatory Affairs or Designee BASIC FUNCTIONS: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance,...


  • Bogota, Colombia ABBVIE A tiempo completo

    Join us at AbbVie, where medicine, aesthetics, and science are powered by some of the brightest minds in the world. We're a dynamic biopharmaceutical company that offers you the resources you need and a global reach that empowers your innovative mindset. From day one, we've known it takes teamwork, passsion, and culture built on diversity and inclusion to...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    Johnson & Johnson Vision, a member of Johnson and Johnson's Family of Companies, is recruiting for a Regulatory Affairs Specialist located preferably in Colombia, or Mexico. An exciting opportunity to join a diverse team. At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating...


  • Bogota, Colombia Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Bogota, CO**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: **Objetivo del cargo Regulatory Affairs Specialist Animal Health**: Respaldar al Director Científico en su actuación ante el Instituto Colombiano Agropecuario en Colombia, con el fin de asegurar el cumplimiento de las regulaciones regionales por parte de la operación de la compania en el país. Colaborar en el proceso de registro para...


  • Bogota, Colombia Genfar A tiempo completo

    **Descripción de la empresa** **_ Elijo Cuidarme, Yo Elijo Genfar_** El lograr una vida plena y saludable es posible. En Genfar, esto se logra a través de su gente; personas con distintas nacionalidades, roles, conocimientos y creencias que luchan constantemente para llevar lo mejor del mundo de la salud, a toda la sociedad con los más altos estándares...