Regulatory Affairs Specialist

Role Purpose

The Country Regulatory Affairs Specialist is responsible for the execution of specific Regulatory Affairs activities at Sandoz country level.

Tasks assigned will support in maintaining the registered products, related texts and artworks, and (supporting) the execution of projects.

Your Key Responsibilities

Your responsibilities include, but not limited to:

Team and culture

• Be seen as an RA expert

Compliance:

• Guarantees regulatory compliance in execution versus standards required for regulatory submissions and ensures adherence to Sandoz standards, and local health authority legislation and expectations

• Guarantees adherence to the relevant (local) procedures, and record management

• Supports RA during internal and external audits and health authority inspections at country level

Activities to support Sandoz and our customers

• Guarantees timely creation & translation of official product information including Patient Information Leaflets, Summary of Product Characteristics (SmPCs) and all labelling (packaging texts into artworks)

• Maintenance of registration files (mainly MRP and DCP). This is done by: Registration maintenance activities, product related text translations; Answering questions from local health authorities; Updating regulatory databases and plans, Local regulatory tasks related to Risk Management Plan (RMP)/ Risk Minimization Activities (RMA) and Dear Healthcare Professional Communications (DHPC) (as per global SOP)

• Guarantees timely implementation of changes of the registered text into artworks

• For the activities in scope of the role ensures that all relevant Key Performance Indicators (including safety label changes, artwork, checklists, deviations, RA input in RMP implementation and DHPC communication), are achieved timely & correctly and that all GxP and RA relevant documents are archived as per specifications.

https://www.youtube.com/watch?v=5_RZsoOZv5c

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

What you’ll bring to the role:

Essential Requirements:

• University Degree, Bachelor or Master in Bio-Medical / Life Sciences / Pharmaceutical sciences.

• Preferably >1 year of relevant work experience

• Italian and English fluent (verbal and written)

• Previous experience in a highly regulated environment
  
  

• Planning, organizational skills and eye for detail

• Accountability for actions, setting own priorities and decision taking

• Result oriented

• High ethical standards

You’ll receive:

• Customized development paths and free access to our on-demand training catalogs

• Job rotation projects that will give you the opportunity to collaborate with global teams

• Corporate Welfare Plan

• Recognition Program to highlight your impact for the organization

• Hybrid Work Model based on flexibility and trust

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)

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