Skip to main content

This job has expired

Regulatory Affairs Labeling Manager Biosimilars (m/f/d)

Employer
Novartis
Location
Holzkirchen
Salary
Competitive
Closing date
Apr 12, 2023

View more

Sector
Pharmaceutical, Regulatory Affairs
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
Job Description

2023 - get part of the globally acting Regulatory Affairs department for Biopharmaceuticals within Sandoz. Sandoz has already received 8 marketing authorizations, that already provide increased access to life-saving medicines to patients worldwide while further Biosimilars are under development.

Labeling plays a central role in our ability to provide accessible medicines that are safe and easy to use since the associated documentation such as leaflets and instructions for use are delivered to health care professionals and patients ensuring them how to handle a specific product.

The Regulatory Affairs Labeling (m/f/d) Manager role is embedded in the Global Regulatory Affairs Department at Sandoz Biopharmaceuticals. In this role you will be responsible for delivering and maintaining global compliance and regulatory approval of all labeling relevant documentation for Biosimilars such as leaflets and instructions for use to the European market as well as to the US and any other country worldwide. Additionally in this role you will coordinate all activities needed to achieve a successful delivery.

The ideal candidate for this role brings solid regulatory labeling experience for Biosimilars, can independently drive regulatory stakeholder interactions (e.g. Notified Body, EMA, FDA), can successfully plan coordinate, develop, and deliver high quality regulatory labeling documents for successful registration of both stand-alone and combination product type Biosimilars.

Your key responsibilities:
Your responsibilities include, but not limited to:
• Primary point of contact for all labeling aspects for Biosimilar registrations for internal and external stakeholders
• Definition and leading of operational activities and implementation of regulatory labeling strategies for specific Biosimilars
• Creation, maintenance and delivery of high quality regulatory labeling documents for the European and the American market which serve as the basis for registrations of combination and stand-alone Biosimilar products worldwide
• Creation and delivery of submission artworks in accordance with most recent internal and authority requirements (i.e. folding boxes, labels, leaflets)
• Leading and Support of the creation of labeling-relevant documentation outside of the EU and the US
• Write and maintain high-quality regulatory documents and responses for Health Authorities and Notified Bodies according to established guidelines, processes, IT
• systems and SOPs, to ensure technical congruency and regulatory compliance while meeting agreed timelines and submission requirements
• Supports audit readiness activities and inspections by several authorities
• Regulatory lead for the development / manufacture of Biosimilars` Labeling, including management of relevant registration, certification, and audit requirements. Operational owner of labeling related deliverables and timelines
• Delivery of responses to requests raised by health authorities
• Review upon current status of medicinal information such as brochures, websites and comparable information material
• Collaboration with external vendors and assurance of appropriate quality and timely delivery of relevant documents, files and certificates
• Member of the device development team to liase with other functions of development to define and achieve the aligned strategy for the product
• Support of regulatory intelligence and regulatory compliance and contributions to continuous improvement of submission process, templates and knowledge transfer within project teams and for creation of newly established processes (e.g. electronic packaging material)

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Advanced University degree or equivalent education/degree in life science/healthcare is required)
• Industry experience working in Regulatory Affairs/Labeling development and maintenance with solid knowledge of relevant regulations and standards
• Fluent in English (oral and written) - with excellent verbal and written communication skills
• Attention to detail and quality focused
• Highly collaborative team player with ability coordinate deliverables cross-functionallyAim for five bullet points
• Experience leading teams and topics and within area of expertise in a matrix environment
• High change agility - ability to adapt quickly & effectively in a dynamic environment.
• Proactively / independently engages with internal and external stakeholders.
• Can clearly communicate complex topics to other experts / stakeholders

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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 here at Sandoz!

Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert