This position will be involved in supporting the gap analysis/readiness planning for key regulatory initiatives such as the EU CTR (Clinical Trial Regulations), EU Pharma regulation, PUDFA etc, across different functions at Regeneron.
Additionally, as required, this position will also be responsible for providing Regulatory Intelligence support for proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization, as well as supporting GxP focused intelligence queries from various departments within the organization.
Strong project management leadership skills in operating in a matrixed organization and in leading sub-teams in achieving project results
Collaborate optimally with cross-functional groups to conduct gap assessments, and to improve standard processes and capabilities to enable implementation
Actively engage & lead meetings across all levels of the organization i.e. project taskforce, sub-teams, senior management and sponsors etc
Proactively develop solution roadmaps and serve as a point of contact to resolve any issues
Lead/support business adoption, change management, communication and training with respect to impacted stakeholders
Communicate optimally with senior leadership; provide data-driven and logical recommendations to support effective decision-making
Provide regulatory intelligence leadership in support of a range of operational study design and operational planning activities. This includes regular updates on new information that could impact clinical trial execution
Collaborate on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders
Functional lead on cross-functional organizational level projects or initiatives in supporting of GxP compliance or requirements
Minimum of 6-8 years experience in the biotech/pharmaceutical industry, preferably with Clinical Operations or related background
Expertise in the drug development and clinical development/lifecycle proces.
In-depth knowledge of regulatory policy impacting drug development and associated guidelines is required.
Knowledge of clinical operations/trials management principles is required i.e. study design/conduct/monitor/implementation/close-out, understanding of scientific/trial-related documents, trial execution, external/CRO relationship management, pharmacovigilance etc.
Experienced in understanding and interpreting regulatory guidelines and documents
Ability to research, analyze and extrapolate critical regulatory information, with a focus on clinical requirements and recommendations
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 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 maternity 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.