Job TitleGlobal Regulatory Affairs Manager - ICO Region
Vacancy Reference Number17973
Work SiteSwitzerland / | CHE - All Regions / Bern
Contract TypePermanent [Full-Time]
Minimum number of years of experience required5 years of experience and more
Our offer
A permanent contract with the leader in innovation and high-tech engineering consulting
A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).
In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva
Your role
Leads the GRA ICO team. Leading the development, preparation and implementation of regulatory strategies to obtain, maintain and extend product development and registrations in the ICO region (Latin America, Middle East, Africa).
Analyze the current situation in the ICO region in terms of processes, team structure, obstacles, challenges and provide a detailed mapped out analysis of the situation incl. suggestions on changes regarding structure, processes and positioning of the ICO region
Provides proactive guidance to internal groups and business partners based on technical and regulatory knowledge towards development of strategic and tactical plans.
Creates and completes local regulatory documents for various submissions including, but not limited to, MAAs and their maintenance, amendments, renewals and variations, and other relevant regulatory filings.
Actively works with project management and Regulatory Operations to ensure appropriate planning, tracking, and alignment of content and timelines for regulatory submissions. Provides updates and manages assigned regulatory submission timelines using the appropriate project management tools.
Provides guidance to all appropriate departments to ensure compliance with applicable regulations.
Your profile
Bachelor's degree in scientific discipline required; advanced degree preferred.
7 years previous experience in pharmaceutical companies or equivalent.
7 years previous experience with submissions in Latin America/Middle East/Africa.
Strong scientific knowledge in chemistry/biology and ability to apply that knowledge to regulatory issues and product development.
Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training.
