Manager RA Regulatory Operations

vor 2 Wochen

Holzkirchen, Bayern, Deutschland Sandoz in Deutschland Vollzeit 80.000 € - 120.000 € pro Jahr

Job Description
Major accountabilities:

  • Manages multiple, large and complex global regulatory submission projects.
  • 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)

Key Performance Indicators

  • Adherence to Sandoz policy and guidelines
  • Project and stakeholder feedback

Work Experience

  • Cross Cultural Experience.
  • Managing Crises.
  • Functional Breadth.
  • Project Management.
  • Collaborating across boundaries.
  • Operations Management and Execution.

Skills

  • Data Analysis.
  • Documentation Management.
  • Must-have: Veeva Vault RIM & GLORIA
  • Lifesciences.
  • Project Management.
  • Regulatory Compliance.

Languages

  • English

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.

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