Duration: 12 months contract, extendable up to 36 months.
The Client team is seeking a Regulatory Affairs Specialist 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.
Advice on regulatory requirements, expected outcomes, and changes to landscape.
Requirements:
Strong information seeking skills and ability to work under moderate supervision.
Bachelor's degree in a life sciences discipline.
A minimum of 5 years of relevant regulatory experience with drug or therapeutic biologic products required.
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.
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