Skip to Main Content

Manager, Regulatory Affairs/ Remote

Kyyba, Inc dba Asen Santa Clara, CA

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Manager, Regulatory Affairs

Duration : 6 months +

pay w2 

General Position Summary/Purpose:

The Manager, under the accountability of the Director, Regulatory Affairs, helps lead teams by providing regulatory strategy and support to global development.  He/she is expected to help support teams and efforts around major filing activities and Health Authority (HA) interaction and meetings, attend and provide regulatory support to other departments, project teams and committees. Organize/manage submissions to health authorities, including IND/CTAs, IND/CTA amendments, NDAs/MAAs, Orphan Drug Application, Breakthrough Applications, safety reports, pre-meeting packages, and NDA post-approval submissions.  This position may have direct interaction with FDA representatives.

Experience:

•             Minimum of five years pharmaceutical/biotechnology industry experience, with relevant U.S. regulatory experience including hands-on knowledge of all aspects of the drug development process.

•             Strong scientific background and experience in critical review and interpretation of scientific/clinical data.

•             Experience/competence in writing regulatory documents (e.g., meeting requests/briefing book activities).

•             Prior work experience in hematology/oncology highly desirable.

•             Ability to interpret FDA/EMA regulations, guidelines, policy statements, etc., and apply to the specific situation at hand.

•             Strong interpersonal skills and the ability to deal effectively with a variety of personnel cross-functionally.

•             Ability to guide, train, supervise and mentor personnel within regulatory affairs department.

•             Are you open to look at candidates willing to relocate? At their own expense

•             Years of experience/education and/or certifcations required:

o             B.S., advanced degree in life sciences preferred (PhD, PharmD, NP/PA, MD, MS, MPH)  Master’s in Regulatory Science

o             Minimum of five years pharmaceutical/biotechnology industry experience, with relevant U.S. regulatory experience including hands-on knowledge of all aspects of the drug development process

•             What are the top 3-5 skills requirements should this person have?

o             Minimum of five years pharmaceutical/biotechnology industry experience, with relevant U.S. regulatory experience including hands-on knowledge of all aspects of the drug development process.

o             Experience/competence in writing regulatory documents (e.g., meeting requests/briefing book activities).

o             Strong interpersonal skills and the ability to deal effectively with a variety of personnel cross-functionally.

o             Proficient with MS office, Powerpoint,Agile

o             Tech Savvy

o             Extremely detailed oriented

•             What is a nice to have (but not required) regarding

Company Description
Kyyba, Inc. is a global workforce management and technology solutions firm headquartered in Farmington Hills, Michigan with multiple locations across the globe. Our expertise is in connecting the right people with the right opportunities. We deliver high-quality solutions and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances. Kyyba offers IT, Engineering, Professional, customized project solutions and Business Consulting Services. Industry areas include but are not limited to Automotive, Education, Financial Services, Public Services, Aerospace & Defense, Insurance, Transportation, Technology, Government, Healthcare & Medical, Manufacturing, and Oil & Energy.

Asen has been in business since 1975 and we are 1st tier preferred vendors for our MSP,VMS clients. Fortune 500 companies. We stay in the top 5 on most recent report cards for IT,Clinical, Creative and Engineering. We are an equal opportunity employer.

Kyyba, Inc dba Asen

Kyyba, Inc. is a global workforce management and technology solutions firm headquartered in Farmington Hills, Michigan with multiple locations across the globe. Our expertise is in connecting the right people with the right opportunities. We deliver high-quality solutions and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances. Kyyba offers IT, Engineering, Professional, customized project solutions and Business Consulting Services. Industry areas include but are not limited to Automotive, Education, Financial Services, Public Services, Aerospace & Defense, Insurance, Transportation, Technology, Government, Healthcare & Medical, Manufacturing, and Oil & Energy. Asen has been in business since 1975 and we are 1st tier preferred vendors for our MSP,VMS clients. Fortune 500 companies. We stay in the top 5 on most recent report cards for IT,Clinical, Creative and Engineering. We are an equal opportunity employer.

Kyyba, Inc dba Asen's Logo

Address

Santa Clara, CA
USA

Industry

Government

View all jobs at Kyyba, Inc dba Asen