Regulatory Affairs Officer
Il y a 2 mois
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
**Major Activities**:
**Team and culture**:
- Be seen as an RA expert, and able to be a project lead.
- Adheres to the Sandoz V&B’s
**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):
- Registration maintenance activities, product related text translations (checks)
- Answering questions from local health authorities regarding registered products.
- Artwork management from change to approved new/revised artwork
- 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.
- Supports or performs timely preparation of regulatory fees and performs the related administrative activities.
- 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.
- Guarantee good and professional communication between internal and external stakeholders.
- Be the in-country SME on RA specific processes, tools and/or projects in scope of the role.
- Lead or support (local) RA projects.
**General Sandoz requirements**:
- Adhere to Sandoz values and behaviors policies
- Adhere to Sandoz's anti-bribery, confidentiality, and ethical standards and policies
- Adhere to relevant GxP and pharmacovigilance requirements as established in the processes and tools
**Ideal Background**:
**Education**:
- University Degree, Bachelor or Master in Pharmaceutical sciences / Bio-Medical / Life Sciences
- Preferably >1 year of relevant work experience
**Languages**:
- Dutch, French and English (verbal and written)
**Professional Experience**:
- A first experience in the pharmaceutical industry (> 1 y)
- Working in a highly regulated environment
**Competencies**:
- Planning, organizational skills and eye for detail
- Strong written communication skills
- 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.
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.
**#Sandoz**
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