Regulatory Affairs Coordinator

hace 3 semanas

Buenos Aires, Argentina Novartis A tiempo completo
766 million lives were touched by Novartis medicines 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:
  • Execute Global/Regional strategies for new products (NCE & BLA), new indications, LCM, RMP /Risk Management Plans and PSURs in Argentina. Interface with Regional Project Coordinators/RA New Products Strategy/ RA Regional Heads
  • Local Legislation: collaborate with the RA GDD Head/RA GDD Managers for reporting/informing new legislations, updates and/or modifications of the local legislation to the Local Leadership team and to the Regional/Global RA.
  • Responsible for ensuring product quality and GxP standard compliance per the corresponding area of responsibility, including the reporting and escalation of any incident or breach related to product quality or GxP standards.
  • Participate in Committee of New Products (CNP).
  • Promotional materials: Active participation in the review of promotional activities to ensure policy compliance and its notification to ANMAT.
  • BD&L: Advise on the regulatory aspects that correspond to each individual case. Brand Max Activities / Regulatory Intelligence.
  • Record Update: Ensure the proper update of records through the assessment of the extent of the changes proposed by Global (Headquarters) in the local records, submission and approval before the HA and subsequent implementation.
  • Comply and enforce compliance by the staff with all practices, programs and procedures related to the health, safety and environmental protection. Actively participate in the HSE Management System including, but not limited to, immediately reporting the health and environmental risks, deficiencies in equipment and/or in the work place, HSE events, attending trainings and/or meetings, reporting problems and recommending improvements.

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:

  • Graduated or advanced student in health sciences (pharmacist, biochemist, biotechnologist, etc.)
  • 35 years of experience working in regulatory affairs in pharmaceutical industry
  • Strong knowledge of current local regulations.
  • Management of regulatory databases
  • Ability to interact effectively across boundaries with other global /local functions using influencing and relationship building skills
  • English and Spanish 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?

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

  • Argentina

Work Location

  • Buenos Aires

Company/Legal Entity

  • Novartis Argentina S.A

Functional Area

  • Research & Development

Job Type

  • Full Time

Employment Type

  • Regular

Shift Work

  • No

Early Talent

  • No

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