Director, Regulatory Affairs (Immuno-Oncology)

Location
Tarrytown, NY, US
Posted
Mar 02, 2018
Ref
8933BR
Required Education
Masters Degree/MBA
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:
This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's quality, preclinical and clinical drug development programs, policies, and procedures, so that development teams are able to meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements. In addition the position assist Regulatory senior management in developing Regulatory strategies/processes across department and therapeutic areas.


JOB RESPONSIBILITIES:
•Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidance's and assessment of drug development in similar indication to obtain approval in support of Regeneron 's development and marketing objectives within specified time lines.
•Is actively abreast of regulatory strategy development across projects and therapeutic areas and assists Regulatory senior management in developing the strategic acumen of the department.
•Liaison responsible for communication with FDA and other health authorities for assigned programs.
•Can support department liaisons with their project specific communications, including Agency meetings as required by Regulatory senior management
•Management of others in the accomplishment of all regulatory activities associated with Regeneron drug development programs.
•Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
•Provide guidance to multi-disciplinary teams on the regulatory requirements to support clinical development, including preparation and maintenance IND or CTA filings. Oversee development of all regulatory filings in support of program.
•Provide critical feedback to teams on study design, statistical analysis plans, and integrated analysis plans
•In collaboration with team, perform/manage critical analysis of data (clinical, preclinical and manufacturing), independently develop, interpret findings and conclusions
•Perform reviews of clinical protocols and of clinical and preclinical study reports with respect to Scientific rigor, clarity, completeness, and regulatory requirements
•Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation.
•As required by Regulatory senior management, develop or enhance existing working processes (including collaborations with Regulatory Operations) to ensure cross-department standardization to foster, more efficient forward thinking approaches.
•Lead teams in the planning, preparation and submission of licensing applications
•Assist with the scientific writing and review of application. Evaluate scientific rigor of our analyses and conformance with the regulatory requirements, and completeness.
•Review and provide input on commercialization activities associated with products;
•Manage timelines and budgets with project management as appropriate and provide progress updates to senior management
•Lead teams in the preparation for FPA Advisory Committee meetings, including preparation of internal and external speakers, review input on slide presentations, and Q&A preparation.
•Represent the company regulatory position with our external collaborators, manage relationships with our collaborator regulatory affairs personnel to ensure the product's objectives are achieved.
•Continually monitor newly published FDA guidelines and international guidance documents and ongoing development programs. Provide training on applicable requirements for scientific staff as required.
•Liaison responsible for communication with FDA and other health authorities for assigned programs. Can support department liaisons with their project specific communications, including Agency meetings as required by Regulatory senior management
•Management of others in the accomplishment of all regulatory activities associated with Regeneron drug development programs.
•Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
•Provide guidance to multi-disciplinary teams on the regulatory requirements to support clinical development, including preparation and maintenance IND or CTA filings. Oversee development of all regulatory filings in support of program.
•Provide critical feedback to teams on study design, statistical analysis plans, and integrated analysis plans
•In collaboration with team, perform/manage critical analysis of data (clinical, preclinical and manufacturing), independently develop, interpret findings and conclusions
•Perform reviews of clinical protocols and of clinical and preclinical study reports with respect to Scientific rigor, clarity, completeness, and regulatory requirements
•Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation.
•As required by Regulatory senior management, develop or enhance existing working processes (including collaborations with Regulatory Operations) to ensure cross-department standardization to foster, more efficient forward thinking approaches.
•Lead teams in the planning, preparation and submission of licensing applications
•Assist with the scientific writing and review of application. Evaluate scientific rigor of our analyses and conformance with the regulatory requirements, and completeness.
•Review and provide input on commercialization activities associated with products;
•Manage timelines and budgets with project management as appropriate and provide progress updates to senior management
•Lead teams in the preparation for FPA Advisory Committee meetings, including preparation of internal and external speakers, review input on slide presentations, and Q&A preparation.
•Represent the company regulatory position with our external collaborators; manage relationships with our collaborator regulatory affairs personnel to ensure the product's objectives are achieved.
•Continually monitor newly published FDA guidelines and international guidance documents and ongoing development programs. Provide training on applicable requirements for scientific staff as required.

Education
•Requires advanced degree in a science related discipline, i.e. MD, PhD, PharmD or equivalent.

Experience

•At least 5 years of regulatory experience.
•Research laboratory, process development or manufacturing experience with biotechnology products highly desirable.
•Must possess excellent written and verbal communication skills
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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.