Regeneron Pharmaceuticals
Senior Manager, Regulatory Intelligence
Regeneron Pharmaceuticals, Armonk, New York, United States, 10504
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. This position will also serve as a lead Reg Intel contact in support of cross-functional requests and initiatives from the Global Clinical Development organization and various functions within the organization’s GxP framework.
In this role, a typical day might include:
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.
To be considered for this opportunity, you must have the following:
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!
#GDRAJobs #GDPSJobs
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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 in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. 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. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$129,800.00 - $211,800.00
In this role, a typical day might include:
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.
To be considered for this opportunity, you must have the following:
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!
#GDRAJobs #GDPSJobs
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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 in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. 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. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$129,800.00 - $211,800.00