Regulatory Affairs Associate

• Description:* A local oncology biotech company is seeking a Regulatory Affairs Associate 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.
• Job 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
• Additional Skills & Qualifications:*
• Bachelor's degree in a life sciences discipline
• 2-4 years of relevant regulatory experience with drug or therapeutic biologic products required
• Oncology experience preferred
• Knowledge of US regulatory requirements and opportunities for expediting development programs for serious conditions
• Able to manage conflicting priorities and adhere to tight timelines
• Able to consider and account for multiple options and opinions
• Verbal and written communication skills, multi-tasking, customer service skills and interpersonal skills
• Ability to work independently and manage one’s time
• Ability to keep information organized and confidential
• Previous experience with computer applications, such as Microsoft Word, Excel and PowerPoint
  
  

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people
  
  

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.