Senior Manager Regulatory Intelligence

6 days ago


Ireland, United Kingdom Regeneron Ireland DAC Full time €12,000

This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization.
Project Management and leadership in the delivery of regulatory intelligence research services and information Collaborating on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders Managing more complex intelligence query requests from internal stakeholders Serving as the functional lead on cross-functional organizational level projects or initiatives in supporting of GxP compliance or requirements This role might be for you if can: Monitor and analyze the external regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders Monitor and analyze global regulatory intelligence sources for the most current changes and information in the drug development space Assess regulatory intelligence information for relevance and impact to company's internal processes, drug development projects and/or regulatory strategies Identify business critical aspects and communicate effectively to internal stakeholders Support project teams, functions and departments through the collection and distribution of requested regulatory intelligence information.
Provide regulatory intelligence 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 as well as ad hoc requests to input into feasibility.
Advanced life science degree or related field Minimum of 6+ years experience in the biotech/pharmaceutical industry with a strong focus in Regulatory Intelligence Good understanding of the drug development and commercialization process, with a focus on clinical development and trial execution 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 Please note, this role requires you to work 3 days onsite weekly out of our New York or New Jersey offices.
If you are not local and qualify, we can offer a relocation package.
#We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off 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.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.



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