Manager RA Regulatory Operations (Information Management) (m/f/d)

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar 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!

Job Description

As a Manager in RA Regulatory Operations-Information Management (ROPS IM Data Governance), you will support the monitoring of implementation of existing, new, and/or updated business processes in structured data submissions, data maintenance, data governance and other regulatory information management aspects. 

In close cooperation with other RA functions, you will manage the availability, usability, integrity, and security of the data in internal systems, based on internal standards and policies. Furthermore, you will identify ways to monitor that updating & maintaining of databases happen in a correct and timely manner and takes steps for identification of discrepancies / inconsistencies. In addition you need to trigger corrective actions and re-trainings where necessary and follows up on the data corrections. 

The Manager in RA Regulatory Operations-Information Management acts as quality and compliance representative. This includes support with activities linked to proper process documentation and operational compliance activities to ensure fit-for-purpose and compliant processes.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Monitor data quality and data compliance in regulatory systems and defines, implements and monitors steps for corrective / preventive actions based on identified data issues.
• Develop and provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
• Contribute to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
• A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
• This job is the fully qualified, career-oriented, journey-level position .
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Networks with senior internal and external personnel in own area of expertise.
• Contributes to many cost center goals and objectives; may contribute to service line goals -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

What you’ll bring to the role:

Essential Requirements & Capabilities:

• University or College Degree in any field or life science with relevant industry experience or comparable degree.
• At least 5 years of professional experience in regulartory and biopharmaceutical industry.
• Managing Crises and Functional Breadth.
• Project Management skills and Collaborating across boundaries are fundamental as well as Cross-Cultural Experience.
• Operations Management and Execution.
• Data Analysis and Documentation Management (Database administration; Knowledge of regulatory requirements on electronic submissions and or structured data submissions)
• Lifesciences and Regulatory Compliance.
• Fluent in English (oral and written).
• Advanced computer skills, specifically but not restricted to MS Excel, problem solving oriented, quality-conscious.

You’ll receive:

Sandoz has an employee-first approach and that’s why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.

In addition to the various learning opportunities, we offer company benefits, such as:

• 30 days of annual leave
• Holiday allowance
• Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)
• Company pension schemes and capital formation benefits
• Parental leave
• Other offerings, such as bike leasing

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.

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 Sandoz Network:

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

#Sandoz

Skills Desired

Data Analysis, Documentation Management, Lifesciences, Regulatory Compliance, Waterfall Project Management

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