Senior Specialist RA Regulatory Operations-Information Management (mwd)

Sandoz; Rosenheim; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

A leading global pharmaceutical company in Rosenheim is seeking an experienced professional to define compliance standard reports and support users in regulatory databases. The role demands a University/College degree and a minimum of 4 years in life sciences or regulatory affairs. You will maintain master data, support audits, and enhance business processes. Competitive company benefits include extensive annual leave and learning opportunities. Join us to shape the future of healthcare!

Leistungen

30 days of annual leave

Holiday allowance

Company pension schemes

Qualifikationen

• Minimum 4 years of experience in life sciences and regulatory affairs.
• Strong interpersonal communication and negotiation skills.
• Ability to operate effectively in an international and cross-functional environment.

Aufgaben

• Define and create compliance standard reports in regulatory databases.
• Support users with report analysis and execution of new requests.
• Maintain master data in regulatory databases.

Kenntnisse

Organization and prioritization of tasks

Interpersonal communication

Fluent English (oral and written)

Negotiation skills

Problem solving oriented

Stakeholder management

Ability to work independently

Ausbildung

University or College Degree in life science or relevant field

Tools

Veeva Vault Regulatory System

MS Office (Excel)

Jobbeschreibung

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path unique opportunities will present themselves both professionally and personally. Join us the future is ours to shape!

Job Description

Your Key Responsibilities:

• 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.
• 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.
• 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)
• 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.
• Support creation and / or maintenance of training materials work instructions and SOPs. Make sure that documentation is archived according to given rules.
• Support compliance projects and operational compliance tasks as assigned.
• Advocate a quality culture.
• Facilitate or support Investigation/Deviation and CAPAS (including trending/monitoring and closure).
• Develop and maintain good working relationships with relevant RA non-RA stakeholders and when relevant Health Authorities.
• Support creation and / or maintenance of relevant training materials work instructions and SOPs. Make sure that documentation is archived according to given rules.
• Support initiatives to improve and / or increase the harmonization of business processes in the area of ROPS and ensure that updated processes are followed.
• Ensure a timely implementation of new or updated business processes on local and global level and support trainings as appropriate.
• Monitor and ensure that RA business intelligence (including regulatory guidelines) is applied to internal processes and systems in a timely matter.
• Support specialists and associates with trouble shooting in their areas of responsibilities as needed.
• Support internal and external audits and inspections as needed with input derived from Sandoz regulatory databases.

What youll bring to the role:

• University or College Degree in any field or life science with relevant industry experience or comparable degree
• Experience with Veeva Vault Regulatory System ideally in the Business Administrator Role
• Fluent English required (oral and written)
• Minimum 4 years experience in life sciences and or regulatory affairs.
• Proven expertise in organization and prioritization of tasks
• Strong interpersonal communication and negotiation skills.
• Ability to quickly familiarize with new IT tools.
• Ability to work independently under pressure demonstrating initiative and flexibility.
• Ability to operate effectively in an international and cross-functional environment.
• Strong organizational and planning skills
• Strong problem solution oriented.
• Very good command over any MS Office application specifically Excel
• Team spirit and embracing diversity of cultures and personalities.
• Stakeholder management capabilities.
• Participating and supporting as necessary in audits/inspections.
• Risk management capabilities.
• Quality and compliance conscious

Youll receive:

Sandoz has an employee-first approach and thats why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200000 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 provided more than 900 million patient treatments across 100 countries in 2024 and while we are proud of this achievement we have an ambition to do more!

With investments in new development capabilities 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 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 supported!

Join us!

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.

Skills Desired

Clinical Study Reports Data Analysis Documentation Management Lifesciences Operational Excellence Regulatory Compliance

Required Experience:

Senior IC

Key Skills Financial Services, Information Technology, Cost Control, Corporate Risk Management, Law

Employment Type : Full-Time

Experience: years

Vacancy: 1