Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
Who are we?
We Are PRA.
We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.
Who are you?
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Senior Manager, Regulatory Strategy CMC, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
What will you be doing?
As a Senior Manager, Regulatory Strategy CMC, you will develops and leads the execution of regulatory CMC development and registration strategies as the RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams for assigned products throughout clinical development and commercial lifecycle with minimal supervision. Develop and apply a comprehensive understanding of global RA CMC regulations and guidelines to projects to enhance probability of regulatory success and regulatory compliance. Manage interactions with international Health Authorities, successfully negotiating RA CMC matters, directly and indirectly. Develop constructive relations with key internal and external colleagues, including Alliance Partners.
What do you need to have?
Education: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.