Job Details

Description

Position summary:

• Team is 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.

Principal Responsibilities:

• 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.
• Strong information seeking skills and ability to work under moderate supervision.

Organizational relationships:

• This person will interact with regulatory colleagues and matrixed project teams that may include clinical, medical, statistics, regulatory publishing and submissions, quality/CMC, medical writers, and other functions as needed.

Education and experience:

• 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

Technical skills requirements:

• 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

Physical position requirements:

• This position may require sitting/standing, focusing on computer screen for long periods of time and interacting with colleagues.

Hard Skills:

• 2+yrs Relevant Exp
• 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