Regulatory Intelligence Manager

Location
Tarrytown, New York, US
Posted
Oct 09, 2018
Ref
13495BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

Proactive monitoring and surveillance on changes in the global regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization. This position will primarily support clinical activities and requests.

Duties:

• Monitor and analyze the external regulatory environment, including guidances 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.

• Produce regulatory intelligence reports or deliverables as it relates to project or process strategies

• Collaborate with cross-functional team from preclinical to commercial to identify and assess key regulatory requirements, regulations, guidances, and information
o Primarily, this role will focus on support of global clinical development requests
o Support of requests from other Parent organization will be secondary

• Synthesize information from global requirements database as well as interaction with local country experts as needed

• Share/Input data into systems or tools to enable effective knowledge management of country level operational intelligence data.

• Conduct the initial analysis of commenting opportunities and assist with drafting of comments for submission to industry organizations, Health Authorities and other stakeholders

• Facilitate regulatory intelligence review meetings and/or lunch-n-learn sessions

• Develop and refine regulatory intelligence processes and procedures to build efficiencies

• Assist in the collection and maintenance of regulatory intelligence newsletter content and distribution to organization

• Manage content of and updates to the Regulatory Intelligence Sharepoint and intranet sites.
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Requirements:

• Advanced life science degree

• Minimum of 2 years experience in the biotech/pharmaceutical industry

• 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

• Highly organized and able to work independently to meet deliverable on time and on target

• Team-oriented and strong relationship builder, ability to effectively collaborate with a range of individuals across the organization at all level

• Attentive to details and focused on quality output

• Effective communicator - - both written and oral - in a multi-discipline team environment.

• Proficient in the navigation of intelligence database(s)

• Prior experience in clinical trial operations

• Basic knowledge in the monitoring and sourcing of regulatory requirements information in pharmaceutical industry

• Minimum of 2 years experience in the biotech/pharmaceutical industry

• Good understanding of the drug development and commercialization process, with a focus on clinical development and trial execution

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.