Role Overview:
We are seeking a highly skilled and experienced professional to join our team as a Clinical Trials and Regulatory Specialist. This is an exciting opportunity for someone who is passionate about making a difference in the lives of patients around the world.
The successful candidate will be responsible for managing the submission content and responses to questions for clinical trials and marketing authorization applications. They will also work closely with internal teams to develop and execute regulatory strategies, manage timelines, and communicate change status effectively.
To succeed in this role, you will need to have a strong understanding of global regulations, guidelines, and regulatory precedents. You will also need to possess excellent communication and problem-solving skills, as well as the ability to work effectively in a team environment.
This is a challenging and rewarding role that offers opportunities for growth and development. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply.
Key Responsibilities:
* Plan and prepare submission content and responses to questions for clinical trials and marketing authorization applications.
* Manage internal requirements and documentation within the Global Regulatory Area and with internal partners.
* Develop and execute regulatory strategies and agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives.
* Manage submission timelines with relevant teams, monitor approval status, and communicate change status to interested personnel in a timely manner.
Requirements:
* Bachelor's degree in a science, engineering, or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Analytical Sciences or similar) with 6–8 years of experience in CMC regulatory or drug substance or drug product development, commercialization, manufacturing, or quality.
* Or master's degree in regulatory affairs or in a science, engineering, or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Analytical Sciences or similar) with 3–5 years of experience in drug substance or drug product development, commercialization, manufacturing, or quality.
* Prior experience authoring CMC submission content is desirable.
* Prior Regulatory CMC experience or equivalent combination of technical and regulatory guidance knowledge is desirable.
What We Offer:
* A competitive salary and benefits package.
* Ongoing training and development opportunities.
* A dynamic and supportive work environment.
About Us:
We are a leading organization dedicated to improving human health. Our team is passionate about making a difference in the lives of patients around the world. We offer a collaborative and inclusive work environment that values diversity and promotes innovation.