We are seeking a Regulatory Affairs Contractor to contribute to the development and execution of effective regulatory strategies for investigational products.
The successful candidate will serve as a regulatory contact within an internal matrixed team environment.
Execute integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients.
Provide support to assigned clinical study and global regulatory teams.
Assess regulatory program risks for likelihood and impact; help to establish mitigation strategies.
Plan and prepare submissions to regulatory authorities, related to IND maintenance.
Advise on regulatory requirements, expected outcomes, and changes to landscape.
Demonstrate strong information seeking skills and ability to work under moderate supervision.
Building a culture of care, engagement, and recognition with clear outcomes.
Requirements:
Bachelor's degree in a life sciences discipline.
5 years of relevant regulatory experience with drug or therapeutic biologic products.
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 to manage conflicting priorities and adhere to tight timelines.
Proven ability to work with a high level of integrity, accuracy, and attention to detail.
Maintaining an inclusive environment through persistent self-reflection.
How strong is your resume?
Upload your resume and get feedback from our expert to help land this job
How strong is your resume?
Upload your resume and get feedback from our expert to help land this job