Regulatory Affairs Associate
100 College Road West NJ USA 093657 Princeton, NJ 093657 US
Target PAY: 55-59/hr
Regulatory Affairs Operations Associate to support submission review, publishing in eCTD format and archiving for ANDAs, NDAs, sNDAs, INDs, DMFs, annual reports and safety reports. Technical document preparation for electronic submission such as bookmark, hyperlink and PDF properties. Ensuring the compliance and deliverables of applicable regulations, guidance requirements, such as documents formats and named in accordance with FDA, ICH guidelines & internal guidelines/SOPs. Engage in life cycle management of submission documents (if necessary) to ensure document integrity in DMS and publishing tool. Track and monitor metrics, maintains submission tracking tool and trackers daily. Utilize Electronic Submission Gateway (ESG) to submit submissions to FDA centers. Utilizing technical skills for learning new features/applications of software which can support to improve the efficiency and complexity. Demonstrates robust communication and listening skills; must be able to effectively identify opportunities and challenges and partner with co-workers in identifying solutions. Other functional duties as requested by management.
Education: Bachelors degree
Experience: 3-5 years of related professional experience in the pharmaceutical industry with 2 of those years in regulatory affairs registration and publishing management.
- Computer knowledge, problem solving skills, working knowledge of regulatory and drug development processes, technical knowledge, innovative and creative and possesses good judgment.
- Good understand of CTD and US FDA registration requirement.
- Adherence to all health, safety & environmental requirements in support of departmental and site HSE goals. Work in a safe and efficient manner.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.