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Regulatory Operations Expert for Life Sciences
2 months ago
We are looking for a highly skilled Regulatory Operations Expert to join our team at Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma, and IT.
As a Regulatory Operations Expert, you will be responsible for performing regulatory operations tasks, including bookmarking and hyper-linking for granular components of submission in accordance with ICH guidelines and other Health Authorities. You will also review and transform Source Documents, perform Quality Control checks for all submission components, and coordinate the essential documentation and resources required for the filing of global applications.
You will have the opportunity to work on electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc.
In this role, you will be expected to demonstrate agility for quick learning, problem-solving skills, ability to perform under pressure, commitment to quality, and ability to work well in a team.
The ideal candidate will have a Bachelor's or Master's degree in Pharmacy and 3-5 years of experience in regulatory operations. They will be able to analyze and solve lower-complexity problems, work independently, and make decisions that impact their own work and may impact the work of others.
We offer a competitive salary of $80,000 - $110,000 per year, depending on experience, and opportunities for professional growth and development. If you are a motivated and detail-oriented individual who is passionate about regulatory operations, we encourage you to apply for this exciting opportunity.
