Regulatory Affairs Manager (m/f)

Novartis
  • Schaftenau
  • Vollzeit
  • Berufserfahrung
  • 12.10.2018

Come join us and become a part of our world. Together we can discover new ways to improve and extend people's lives. As part of the global Novartis Group our sites in Kundl and Schaftenau are specialized in development and production of antibiotics and biologics.

Regulatory Affairs Manager (m/f)

Biopharmaceuticals / Schaftenau

Area of Responsibility

  • Provide regulatory input and strategic support for biopharmaceutical products in development, registration or maintenance phase while respecting agreed strategies, assuring technical congruency and regulatory compliance, and meeting timelines and e-publishing requirements
  • Information about regulatory requirements of various authorities
  • Input to the preparation of development documents (e.g. input to development plan, IMPD, scientific advice briefing books, clinical study protocols….)
  • Development of the regulatory strategy for the submission of new projects, variations etc.
  • Input to general Development Concepts
  • Independent and timely compilation and preparation of high quality regulatory documentation for complex global regulatory submissions in various countries to support development activities and routine maintenance, and to ensure obtaining rapid and advantageous approvals
  • Liaise with Regulatory Authorities and prepare responses to health authority questions during development, registration, and product lifecycle

Qualifications

Education: University degree in natural sciences, PhD or alternatively several years of regulatory or other relevant industry experience or comparable qualification
Languages:fluent in English and German
Experience: a few years of work experience in biotech RA

Please apply online under the following link Online Application (Job ID 247437BR)
Contact: Jennifer Kriedemann, Talent Acquisition & Staffing Business Partner

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 44286.62 per year).

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

Novartis

Pharma, Chemie, Biotech
501+ Mitarbeiter

Über uns

Als Teil der weltweiten Novartis Gruppe sind wir an den Standorten Kundl und Schaftenau auf die Entwicklung und Produktion von Antibiotika und Biologika spezialisiert.