At Roche Product Development Regulatory Affairs we are determined to transform drug development and deliver novel medicines with outstanding benefit to patients at lower costs for the society.
We want you to join us on this quest!
We currently have an opportunity to join our team in Basel or Welwyn.
The Clinical Regulatory Strategy Lead (EU) provides strategic guidance and regulatory expertise to ensure impactful regulatory input into drug development programmes.
Working independently, as well as within a regulatory sub-team, you participate in and represent the regulatory function on cross-functional global teams in early and/or late stage projects.
You lead the successful execution of filings, coordinating and/or leading cross functional teams in the development and implementation of regulatory strategies for the development of Roche products in the EU and other key countries.
You lead interactions and negotiations with Health Authorities for Roche drug development programmes and project-related issue management in these countries for CTAs, Scientific Advice and Qualification Advice and/or for MAA/variations.
You are accountable for the development of key regulatory communications for Health Authorities and internal stakeholders for a programme.
As the primary contact with Affiliate Regulatory Affairs, you ensure Affiliates are informed of project developments and activities, enabling dialogue and their contribution in all relevant project/program developments and activities.
Well informed about regulatory trends, you are able to address and anticipate business requirements.
Who are we looking for?
- We are looking for a passionate and committed individual with a deep regulatory knowledge and the experience and ability to manage complex issues with meticulous efficiency. You do bring:
- Excellent understanding of regulatory science and innovative clinical drug development, e.g. sound knowledge of EU legislation, guidelines and procedures, successful management of regulatory procedures, direct interaction with Health Authorities and strategic regulatory input in drug discovery and development, especially clinical aspects
- Demonstrated leadership competencies: you are a strategic thinker with exceptional communication skills at all levels. You have a passion for and you are skilled at identifying, coaching and developing talents. You are admired for your inclusive way of working and your influencing skills.
- A growth attitude: you are excited about learning through experience. You want to make a difference and find excitement in innovating practices, therapeutics and processes
- Feel comfortable thinking on your feet and thrive in fast paced, ambiguous and highly collaborative environments
- Fluency in both written and spoken English
We are flexible in our working approach and open to consider remote working wherever it is legally appropriate.
At Roche, we believe our people are Key to our success in bringing novel medicines to patients and we are fully dedicated to being a great place to work and to provide the services, tools and the environment where everybody feels empowered, trusted and is enabled to uncover his/her true potential.
Are you interested in this position and have additional questions? Please check our FAQs and videos on careers.roche.ch/faq.
Roche is an equal opportunity employer.Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs