ProClinical is happy to announce that we are advertising an opportunity for a talented and hardworking individual to join a Regulatory Associate position at a large global pharmaceutical company with leading products across various therapeutic areas. Joining the company in their US-based team, the Regulatory Associate will have the opportunity to work with a company that develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally.
- Preparing of high quality, Chemistry, Manufacturing, and Control ( CMC) detailed regulatory documents using varied information sources.
- Liaising closely with other personnel to ensure the accuracy of such records.
- Working to agreed deadlines and maintain records to reflecting project status.
- Responsible for promptly highlighting potential delaying factors to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving.
- Proactively pursuing process improvement and sharing of best practices.
- Establishing strong relationships and liaising effectively with sites worldwide.
Skills and Requirements:
- Demonstrable CMC experience.
- A proven ability to focus and work with attention to detail, along with retaining critical information.
- Proven knowledge of the contents of a marketing authorisation application.
- Strong communication, persuasion, presentation, and interpersonal skills.
- Proficiency in the use of IT packages, such as the Microsoft Office Suite.
- Strong problem-solving skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Bershara on +267-477-3355 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Warren, New Jersey
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