Head Regulatory Devices Group

  • Kundl
  • Vollzeit
  • Berufserfahrung
  • 4.11.2019
  • Stelleninserat
  • Arbeitgeber Einblicke
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Head Regulatory Devices Group

Join us to find new ways to improve and extend people's lives! As part of the global Novartis Group our sites in Kundl, Schaftenau, Unterach and Vienna are specialized in development, production and distribution of pharmaceutical products.

Verantwortungsgebiet
Head Regulatory Devices Group (m/f/d), Schaftenau, Austria

1! The first biosimilar approved anywhere in the world! Be a member of the regulatory team that made this happen and be responsible for the entire portfolio of biosimilar products as the Head of Regulatory Devices within Regulatory Affairs Sandoz Biopharmaceuticals (RASB). As a member of the RASB Leadership Team and Head of Regulatory Devices, you will represent the function on executive committees and work in an international environment with regular global interactions.

Your Responsibilities:

Your responsibilities include, but are not limited to:

  • Responsible for the development of world-wide regulatory strategy pertaining to stand-alone device, and combination device products.
  • Lead the Medical Device Group within RASB (Regulatory Affairs Sandoz Biopharmaceuticals) by monitoring and tracking progress of projects as well as prioritizing project activities.
  • Represent RASB in device governance boards.
  • Provide leadership for the preparation of medical device dossiers for stand-alone device submissions and device specific documents for regulatory submission of combination products and correspondence, including Briefing Books, CTAs, MAAs in different HRM regions.
  • Effectively address regulatory issues that may surface in the course of regulatory review of new or existing products (stand-alone device registrations and combination products) and prepare regulatory affairs responses to notified bodies (NB) and health authorities (HA) during development, registration, and product lifecycle.
  • Supervise and prioritize the assignments of device team leaders to assure compliance with regulatory agency regulations and timely submissions to support team objectives. Conduct annual performance settings, mid-year and end-year reviews, as well as sponsor the development needs of people supervised.
  • Provide high-quality device documentation during development and product registration and for marketed products, respecting agreed regulatory strategies, assuring congruency and regulatory compliance, meeting agreed upon timelines and (e-)publishing requirements.
  • Identify issues and provide guidance to employees with social competence, manage conflicts, build talent pipeline.

Qualifikationen
What you'll bring to the role:

  • University degree in natural sciences, PhD or comparable qualification
  • Fluent English required (oral and written)
  • At least 5 years of working in global regulatory affairs for medical devices
  • Demonstrated knowledge of the biotech drug development process
  • At least 3 years of proven successful leadership experience
  • Previous experience in Health Authority interactions

Why consider Novartis?
750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.

We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR 67,292.12 per year on a full time basis)

We are Sandoz, a Novartis Division. Join us and help us reimagine medicine.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Tel. 05338/200-0
www.novartis.at

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