This position will perform functions assigned to Associate level employees while also taking on more advanced responsibilities to support the Regulatory Affairs department.
- Assist in management of regulatory affairs drug product projects through entire lifecycle from initiation through commercialization
- Assist in authoring, reviewing, and submitting to the FDA original INDs, NDAs, ANDAs, supplements, amendments, annual reports, and periodic adverse event reports in both paper and electronic CTD format. Reviews all CMC documentation related to submissions for content accuracy. Occasional electronic publishing of submissions may be required.
- Assist the regulatory representative on cross functional teams supporting products throughout varied stages of development and commercialization on an as-needed basis. Understands and supports regulatory and cross-functional project strategies and submission timelines.
- Assist in maintaining regulatory project timelines that incorporate all submission requirements including clinical and labeling functions.
- Gather required data as needed to defend regulatory filing strategy.
- Author and review departmental SOPs, as well as any additional SOPs that may impact regulatory affairs.
- Monitor various websites and publications to gather regulatory intelligence on proposed product pipeline and any associated information.
BS in science or related field with three or more years of applicable experience.
Required Experience & Technical Requirements
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
- Excellent verbal / written communication skills.
- Availability and willingness to travel as necessary.
- Experience filing electronic CTD submissions in the US is preferred.
- Experience with regulatory timeline development and tracking is preferred.
- US Regulatory Affairs Certification is desirable.Brief Description/Overview:
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com. No hard copy resumes will be considered.
Purdue Pharma L.P. - 2 years ago
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