Regulatory Affairs Contractor

Job Title: Regulatory Contractor

Find out more about this role by reading the information below, then apply to be considered.
Location: USA - NC - Remote open to other Hybrid from any Pfizer work location
Hours/Schedule: M-F, 8 am – 5 PM
Type: Contract

The successful candidate will serve as a regulatory contact within an internal matrixed team environment.

Requirements Bachelor's degree in a life sciences discipline.
2+ years of relevant regulatory experience with drug or therapeutic biologic products required.
Oncology experience preferred.
General knowledge of the drug development process and US regulatory requirements, including expedited development programs for drugs to treat serious conditions
Strong verbal and written communication skills.
Strong organizational skills, ability manage conflicting priorities and adhere to tight timelines.
Proven ability to work with a high level of integrity, accuracy, and attention to detail.
Provide support to assigned clinical study and global regulatory teams. (engagement)
Plan and prepare submissions to regulatory authorities, related to IND maintenance. (Word, PP, Excel)
Advise on regulatory requirements, expected outcomes, and changes to landscape..

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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