Regulatory Affairs Contractor in Bothell, WA

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

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. We specialize in attracting and retaining talent globally for rewarding careers in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, whether in the USA, UK, India, or Ireland. Additionally, we offer Flexible Work Arrangement jobs and contract positions across different verticals and industries.
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