My client is a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases. They are seeking a Manager or Senior Manager of Regulatory Submissions Publishing to lead the eCTD publishing for an upcoming BLA and an MAA. You will build and manage timelines for regulatory publishing activities while managing and mentoring a junior staff member. Now is an exciting time to join the gene therapy revolution!
- Develop and implement regulatory eCTD submission project and resourcing plans for major marketing applications in the US and EU
- Establish goals, and measure progress toward critical milestones for major regulatory submissions
- Manage vendors to support regulatory submissions goals
- Partner with regulatory team members as well as well as members of the Project Management, Commercial, Clinical, Medical Affairs, Clinical Operations, Nonclinical, CMC and Quality functions to ensure successful submissions
- Foster a team culture of ownership and accountability including continuous evaluation, recognition, and process improvement
- Effectively communicate on the status, objectives, risks, and mitigation plans associated with the various regulatory projects
Knowledge & Skills:
- 5+ years of regulatory operations experience, preferably with major marketing application experience
- 2+ years of regulatory submission management experience in a fast-paced, innovative drug development environment
- Proven ability to successfully plan for and manage simultaneous major marketing applications while overseeing the routine daily maintenance of existing regulatory applications.
- Successfully manage regulatory submissions projects such that they integrate effectively with the overall objectives of the development programs they support
- Expertise using MS Office software suite, including Word, Excel, Visio, and Project
- Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations
- Outstanding communication, analytical, and organizational skills
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
NOTE: Qualified candidates must be legally authorized to be employed in the United States. Client cannot support an H1B transfer.