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Job Description
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!
As (Country) Regulatory Affairs Specialist, you are responsible for the execution of specific Regulatory Affairs activities at Sandoz country level.
Tasks assigned will support in obtaining and maintaining the (to be) registered products, related texts and artworks, and (supporting) the execution of projects.
Major Accountabilities:
Responsibilities include but not limited to:
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. This is done by (non-limitative list):
o Registration maintenance activities, product related text translations (checks)
o Answering questions from local health authorities regarding registered products.
o Artwork management from change to approved new/revised artwork
o Updating regulatory databases and plans
o 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
* Supports or performs timely preparation of regulatory fees and performs the related administrative activities.
* Supports achieving the earliest acceptance of registration applications, launches and product site transfers.
* Provides regulatory support (general and product-specific) to the internal organization (e.g. Business Units and Portfolio & Launch, Medical)
* Plays an active role in the local launch team to achieve the company’s business objectives.
* 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.
* Guarantees good and professional communication between internal and external stakeholders.
* Acts as the in-country SME on RA specific processes, tools and/or projects in scope of the role.
* Leads or supports (local) RA projects.
What you’ll bring to the role:
Minimum Requirements:
* University Degree, Bachelor or Master in Pharmaceutical sciences / Bio-Medical / Life Sciences.
* Fluent English and German (written and spoken) is a must. French desirable, Italian beneficial.
* Minimum 1 year of experience in the pharmaceutical industry, and previous experience of working in a highly regulated environment.
* Planning, organizational skills and eye for detail.
* Strong written communication skills and adequate communication with authorities.
* Data management and IT skills (MS Office package / SAP).
* Accountability for actions, setting own priorities and decision taking.
* Result oriented.
* High ethical standards.
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!
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.
Accessibility and accommodation:
Sandoz is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please send an e-mail to claire.gratton@sandoz.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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)
#Sandoz
Skills Desired: Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance
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