The Associate Director, Regulatory Submission Management will be accountable for leading, developing, and mentoring members of the Regulatory Submission Management (RSM) team, which includes supervising staff who are responsible for handling submissions such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). We expect the Associate Director to be independent and critical thinking, provides subject matter input, and support and backup to management as needed.A typical day might include the following:
This role might be for you:
- Responsible for ensuring consistency and standardization to regulatory submissions across programs
- Provides mentorship to RSM team members and cross-functional groups to resolve issues related to submission schedules, documents readiness or other submission or regulatory-related requirements that could impact the submissions
- Liaises with Regulatory Publishing on publishing timelines and resourcing for major submissions and provides input to Regulatory Project Management (Reg PM) on submission timelines and potential resource issues
- Identifies and communicates regulatory system improvement needs or technical issues to management, and provides proposed solutions to areas requiring system enhancements, new or revised processes, or further training or clarifying communications
- Provides oversight on regulatory compliance submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, and promotional pieces
- You have proven understanding of Regulatory Agency regulations, guidelines and specifications
- You have led teams before
- You can work in a high pace environment and handle changing priorities
To be considered for this opportunity, we are looking for you to have a Bachelor’s Degree and 10 years of shown experience. We expect a majority of your experience to be focused in Regulatory Affairs Submission Management including having knowledge of eCTD, submission systems, eDMS systems and MS Suite products.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.