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 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 Manager, Regulatory Strategy CMC, you will develop and lead 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. Develops comprehensive understanding of global RA CMC regulations and guidelines, and apply that knowledge to enhance probability of regulatory success or enhancing regulatory compliance. Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly, with moderate supervision. Interacts with other internal and external colleagues, as well as with other functional areas and 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.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.