Senior Manager, Regulatory Affairs and Operations
Concord, MA or Remote
This person will be responsible for participating in the development and implementation of regulatory strategy for assigned programs. Working in a team environment, the Senior Manager, will be responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials, product registration, and post marketing requirements (PMRs). The Senior Manager will represent the department on multidisciplinary product development teams. The Senior Manager, RA is effective in collaborating within the organization and provides guidance to team members towards achieving the assigned program/project objectives, manages program risks and optimizes development strategies aligned to corporate objectives.
The Senior Manager, Regulatory Affairs and Operations (RA) will report to the Director, Regulatory Affairs and Operations. This position can be located remotely. Travel to the Tremeau home office in Concord, MA will be required at specific times when the global COVID-19 pandemic no longer requires travel or in-office restrictions.
Key Responsibilities
- Work with the Director, RA to develop regulatory strategies for assigned projects or product(s) across all phases of product development aimed at achieving marketing authorization and target product labeling.
- Serve as regulatory representative on cross-functional teams and lead sub-teams to meet development program objectives.
- Plan, review and prepare investigational new drugs (INDs), new drug applications (NDAs) and all related annual reports, amendments, supplements, and continued maintenance of approved marketed products.
- Primary regulatory liaison for interfacing with Health Authority for assigned products/projects.
- Participate in regulatory agency meetings for assigned products including meeting planning, preparation, execution and ensuring submitted documents are of the highest quality. This includes working with the RA Director to develop, prepare and manage the content and timelines for meeting requests, briefing books, etc.
- Lead cross-functional teams in the planning and execution of responses to regulatory authorities
- Work with Operations network to establish and meet timelines for regulatory submission QC and transmittal.
- Regularly report to management on progress against objectives and plans.
- Plan and direct projects and provide technical background, concept ideation, and experiential consultation to cross-functional colleagues as well as other members of the organization.
- Keep abreast of and communicate changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions.
- Support and participate in the development of Quality systems and processes.
- Other Regulatory Affairs duties as assigned or as business needs as required.
Requirements
Tremeau offers a competitive salary and benefits package. To apply, please fill out the information below or send your resume to careers@tremeau.com and include the job title in the subject line. No recruiters please.
