Join the World's Top Legal Talent Network

Description:

• Coordinates and prepares document packages for regulatory submissions in alignment and compliance with local and regional registration requirements as well as with company policies
• Interacts effectively with functional departments in order to facilitate documentation requirements for submissions, ensuring departmental timelines are achieved. Communicates and coordinates regulatory activities with other departments, as needed
• Monitors and collects assigned deliverables required for regulatory submissions
• Compiles all materials in an orderly fashion to facilitate timely submission to the FDA
• Reviews submission materials for errors or other content issues prior to submission.
• Maintains regulatory files (including submissions and correspondence) for Investigational New Drugs (INDs), Clinical Trial Authorizations (CTAs) and other regulatory applications
• Completes regulatory forms at the direction of Regulatory management
• Assists in the preparation of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required to maintain ongoing INDs, CTAs and other applications in good regulatory standing
• Reviews change controls for regulatory approval
• Reviews SOPs pertaining to Regulatory Affairs
• Participates in cross-functional project teams to facilitate activities associated with regulatory affairs
• Keeps project lead informed on status and timelines of pending submissions and any associated correspondence from Regulatory authorities
• Keeps abreast of regulatory procedures and changes
• Supports process initiatives related to new/emerging regulatory requirements, working with Regulatory Affairs colleagues and other functions to develop standard ways of working and process documents as needed

Additional Skills & Qualifications:

• Minimum of 5 years’ experience in the pharmaceutical or related industry
• Regulatory and drug development experience is required
• Ability to understand and explain detailed regulatory affairs and compliance programs and/or issues
• Ability to comply with changing regulatory procedures

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.