Senior Specialist RA Regulatory Operations-Information Management (m/w/d)

Novartis; Deutschland; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

An established industry player is seeking a dedicated individual to join their team as they embark on an exciting transformation. This role involves defining compliance standards, creating reports, and supporting regulatory affairs in a collaborative environment. The ideal candidate will possess a strong background in life sciences, excellent analytical skills, and a commitment to quality and compliance. With a focus on personal growth and professional development, this opportunity offers a chance to make a meaningful impact in the field of sustainable medicines. Join a dynamic team that values diversity and innovation, and contribute to shaping the future of healthcare.

Leistungen

30 days of annual leave

Holiday allowance

Company pension schemes

Parental leave

Bike leasing

Access to learning platforms

Qualifikationen

• 4+ years of experience in life sciences or regulatory affairs.
• Strong communication, negotiation, and organizational skills.

Aufgaben

• Create compliance reports and maintain master data in regulatory databases.
• Support IT system projects and facilitate training materials.

Kenntnisse

Data Analysis

Documentation Management

Regulatory Compliance

Clinical Study Reports

Operational Excellence

Ausbildung

University or College Degree in any field or life science

Tools

MS Office (Excel)

Jobbeschreibung

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

Your Key Responsibilities:

1. Defining and creating compliance standard reports (data extracts) in Sandoz regulatory databases, qualified to monitor the data quality related to comprehensible logical data entries. Execution of such reports, analysis and coordinating / processing of necessary follow-up action, such as triggering the closing of identified process gaps, or training gaps.
2. General support for users to work with reports, extracted from Sandoz regulatory databases, including analysis and execution of new report requests, support in analysis of options and best practice sharing.
3. Maintenance of master data (pick list values, code lists) in Sandoz regulatory databases. This includes verifying that Sandoz is aligned to external authority code lists where applicable (IDMP, xEVMPD, MedDRA, etc)
4. In close cooperation with ROPS BA support IT system projects in all phases such as configuration, migration, system validation and roll-out. Responsible for development of new/updated business processes, user requirements etc.
5. Support creation and / or maintenance of training materials, work instructions and SOPs. Make sure that documentation is archived according to given rules.
6. Support compliance projects and operational compliance tasks as assigned.
7. Advocate a quality culture.
8. Facilitate or support Investigation/Deviation and CAPAS (including trending/monitoring and closure).
9. Develop and maintain good working relationships with relevant RA, non-RA stakeholders and - when relevant - Health Authorities.
10. Support initiatives to improve and / or increase the harmonization of business processes in the area of ROPS and ensure that updated processes are followed.
11. Ensure a timely implementation of new or updated business processes on local and global level and support trainings as appropriate.
12. Monitor and ensure that RA business intelligence (including regulatory guidelines) is applied to internal processes and systems in a timely matter.
13. Support specialists and associates with trouble shooting in their areas of responsibilities as needed.
14. Support internal and external audits and inspections as needed, with input derived from Sandoz regulatory databases.

What you'll bring to the role:

1. University or College Degree in any field or life science with relevant industry experience or comparable degree.
2. Fluent English required (oral and written).
3. Minimum 4 years' experience in life sciences and or regulatory affairs.
4. Proven expertise in organization and prioritization of tasks.
5. Strong interpersonal, communication and negotiation skills.
6. Ability to quickly familiarize with new IT tools.
7. Ability to work independently, under pressure, demonstrating initiative and flexibility.
8. Ability to operate effectively in an international and cross-functional environment.
9. Strong organizational and planning skills Strong problem solution oriented.
10. Very good command over any MS Office application, specifically Excel.
11. Team spirit and embracing diversity of cultures and personalities.
12. Stakeholder management capabilities.
13. Participating and supporting as necessary in audits/inspections.
14. Risk management capabilities.
15. Quality and compliance 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:

1. 30 days of annual leave.
2. Holiday allowance.
3. Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.).
4. Company pension schemes and capital formation benefits.
5. Parental leave.
6. 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
Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance