Location: Rockville,MD, USA
Regulatory Operations Director
Job Description
Provide regulatory operations expertise and leadership to cross-functional teams supporting the pipeline. Train and lead regulatory operations personnel reporting into this role.
Responsibilities
+ Lead the development, refinement, and implementation of internal processes, procedures, work instructions, and training programs for submission production and operational support activities.
+ Oversee full implementation, maintenance, and optimization of a RegDocs Connect RIM system.
+ Provide RIM system leadership by overseeing the development of RIM projects based on current and future business needs.
+ Oversee and manage all Regulatory Operations global submissions, systems-related projects, and submission compliance.
+ Oversee management of external publishing vendor.
+ Ensure proper maintenance of regulatory submissions filing, Health Authority correspondence logs, and archival of previous regulatory submissions.
+ Oversee the build of submission binders and content plans for future regulatory submissions globally.
+ Stay current with regulatory requirements and industry best practices.
+ Prepare and present regulatory reports, metrics, and support budgeting and forecasting activities for the Global Regulatory Operations function.
+ Proactively identify process improvement opportunities which align with business needs, and propose and deploy solutions as needed.
Essential Skills
+ Strong communication skills and proactive attitude.
+ Experience in small biotech or pharmaceutical companies.
+ Experience with filing NDAs/MAAs.
+ 10+ years of experience in regulatory operations.
+ Vendor management experience and relationship-building skills.
+ Experience with negotiating and evaluating vendors and assessing RFPS (request for proposals).
+ Understanding of different regulatory systems, especially non-Veeva RIM systems.
+ Extensive experience managing NDA/regulatory submissions with a large volume of documents.
+ Strong submission experience (90% US based, 10% EU).
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 ...@actalentservices.com ( ...@actalentservices.com) for other accommodation options.