Regulatory Affairs Associate (m/w/d)

für Tirol

Capgemini Engineering combines, under one brand, a unique set of strengths from across the Capgemini Group: the world leading engineering and R&D services of Altran – acquired by Capgemini in 2020 – and Capgemini’s digital manufacturing expertise. With broad industry knowledge and cutting-edge technologies in digital and software, Capgemini Engineering supports the convergence of the physical and digital worlds. Combined with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 52,000 engineer and scientist team members in over 30 countries across sectors including aeronautics, automotive, railways, communications, energy, life sciences, semiconductors, software & internet, space & defence, and consumer products. Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology.

Unser Angebot:

• Exciting, self-organized and responsible tasks
• Long-term employment relationship, pleasant working atmosphere in a young, dedicated team
• Flexi time agreement, flexible working time model, work-life balance
• Opportunities for specialization and subject-specific further education and training
• Extremely collegial team with a friendly approach
• Various development opportunities within the Capgemini Engineering Group

Deine Aufgaben:

• Support all aspects related to the planning, coordination, preparation of high quality labeling documentation (CTD documents)
• Support all aspects to tracking, compilation, publishing and technical quality control of all assigned regulatory submissions (initial submissions and variations during life cycle) with other functions
• Ensure adherence to internal standards and processes, as well as Health Authority’s requirements
• Manage Submission Publishing of all submissions from a Global perspective and dispatches to worldwide Health Authorities
• Support preparation of high quality labeling documentation (CTD documents) in non-EU countries and during implementation of prompt and complete responses to regulatory labeling relevant queries from various stakeholders (e.g. Health Authorities, COs)
• Support defining and implementing regulatory strategy for above-mentioned activities through participation in Global Program Regulatory Sub-Teams

Dein Profil:

• University entrance level
• Ability to work effectively in a matrix environment in a multi-cultural setting
• Ability to plan and prioritize workload
• Proficient in English (oral and written)
• Strong communication, negotiation and interpersonal skills
• Ability to work in interdisciplinary teams

The gross annual salary is at least EUR 50.000EUR but of course we offer overpayment in line with the market, depending on qualifications and professional experience.

WE LOOK FORWARD TO YOUR ONLINE APPLICATION!

Capgemini Engineering Recruiting Team
[email protected]
www.altran.com/at