Regulatory Specialist
6 days ago
**Company Overview**
Inventiv Health Clinical SRE, LLC is a leading provider of clinical solutions for the pharmaceutical and biotechnology industries. Our team of experts is dedicated to delivering high-quality services that meet the evolving needs of our clients.
**Job Description**
We are seeking a highly skilled Regulatory Associate/Sr Regulatory Associate to join our team. In this role, you will be responsible for preparing and submitting regulatory documents, conducting quality control reviews, and maintaining regulatory databases.
Key Responsibilities:
- Prepare Module 3 sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations, and other lifecycle maintenance activities according to current government regulations and guidelines.
- Prepare and submit full applications or components of IND, marketing, and lifecycle maintenance applications to ensure compliance with government acts and regulations.
- Undertake information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.
- Conduct Quality Control reviews of documents and send them out for review, track until final submission or delivery to the client.
Qualifications:
- Master's degree in Pharmacy or equivalent combination of education and experience.
- Minimum 6 months of experience for Regulatory Associate and minimum 1.5 years of experience for Sr Regulatory Associate role.
- Excellent interpersonal/communication skills.
- Advanced skills in Microsoft Office Applications.
- Hands-on experience on RIM systems such as Veeva RIMS and Trackwise, would be preferred.
About Us
We are committed to providing our employees with opportunities for growth and development. We believe in creating a workplace culture that is inclusive, supportive, and rewarding.
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