Summary:

　　The Senior Manager of Regulatory Operations (Reg Ops) is responsible for supporting key functions within the Regulatory Operations team and across the organization. This includes the planning, submission management, and submission of regulatory applications, reports, and other documents required for product approvals and maintaining a compliant US License Marketing Authorization requirement, for biologics and devices products. The Senior Manager plays a critical role in ensuring compliance with regulatory requirements and enabling successful product development and distribution activities, for process improvement, vendor management, functional excellence, compliance with regulatory guidelines, regulatory health authority interactions, team management, leadership, and document management systems (RIMS).

　　Description:

　　• Will be dealing with lots of regulatory submissions

　　• A good chunk of the job is working with systems – this person will need to manage the regulatory information management system

　　o Will have to take ownership of this

　　• Will work cross-functionally

　　• No direct reports right now, but they do have headcount for Q1/Q2 next year for a Manager level to report to this person

　　Skills:

　　Regulatory, Regulatory submission, CRO, biologics

　　Additional Skills & Qualifications:

　　Must haves:

　　• Bachelors – around 8-10 years regulatory operations experience required

　　o If Masters/PhD – around 4-6 years regulatory operations experience required

　　• Industry experience ideal

　　o Sponsor or CRO experience

　　o CRO experience is fine because they will be interacting with people in the industry

　　o If they have hospital experience with some regulatory operations exposure still send, but will need at least a year experience

　　• Biologics/device preferred, not required

　　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.