Senior Regulatory Affairs Associate
- Employer
- Baylor College of Medicine
- Location
- Houston, Texas
- Closing date
- Mar 9, 2022
View more
- Discipline
- Other, Legal/Regulatory Affairs
- Position Type
- Full Time
- Job Type
- Research Scientist
- Organization Type
- Academia
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Summary
The Senior Regulatory Affairs Associate is responsible for handling the regulatory affairs for both internal investigator initiated studies and sponsored studies and requires in depth knowledge of regulatory affairs and clinical research. Will serve as the main point of contact for assigned sponsored studies and investigator initiated studies including communications (and submissions to as appropriate) with CAGT investigators, IRB, other internal agencies. This position will also be responsible for the preparing of submissions to the FDA including: IND annual reports, safety reports, amendments to protocols and coordination and preparation of investigator initiated IND study new submissions. This position will be 80% remote.
Job Duties
Minimum Qualifications
Preferred Qualifications
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
The Senior Regulatory Affairs Associate is responsible for handling the regulatory affairs for both internal investigator initiated studies and sponsored studies and requires in depth knowledge of regulatory affairs and clinical research. Will serve as the main point of contact for assigned sponsored studies and investigator initiated studies including communications (and submissions to as appropriate) with CAGT investigators, IRB, other internal agencies. This position will also be responsible for the preparing of submissions to the FDA including: IND annual reports, safety reports, amendments to protocols and coordination and preparation of investigator initiated IND study new submissions. This position will be 80% remote.
Job Duties
- Serves as the main point of contact for assigned studies and handling the regulatory affairs for both internal investigator initiated studies and sponsored studies.
- Tracks and submits renewals of studies; tracking the overall status of each study on a study status spreadsheet which can be shared with upper leadership.
- Communicates (and submits as appropriate) with CAGT investigators, IRB, other internal agencies.
- Prepares submissions to the FDA including: IND annual reports, safety reports, amendments to protocols and coordination and preparation of investigator initiated IND study new submissions.
- Maintains multiple deadlines (for multiple studies), as well as follows up on regulatory items required for activating studies.
- Drafts, summarizes when necessary and prepare electronic submissions for new protocols, as well as amendments, unanticipated problems and renewals.
- Assists and advises investigators on their compliance with federal and international regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies.
- Interacts and submits to IRB and IBC (including new protocols, amendments, renewals, unanticipated problems).
Minimum Qualifications
- Bachelor's degree.
- Four years of relevant experience.
Preferred Qualifications
- Research certification, such as CCRC, CCRA, CCRP, CIP, RAC.
- Heavy experience with multiple deadlines and heavy experience with multi tasking is preferred.
- Proficient with Microsoft Word, Excel and Adobe.
- Experience with project management.
- Skill in technical writing and summarization for preparing documents to be submitted to the FDA.
- Must be able to apply a detailed understanding of federal and international regulatory requirements when preparing regulatory review applications.
- A keen attention to detail and high level of organization is required in order to maintain multiple deadlines (for multiple studies) as well as following up on regulatory items required for activating studies (which may include highly technical detailed reports or documents needed to send to the FDA).
- Requires a high level of professional business communication, which includes correspondence with various individuals in the college.
- Requires skill in technical writing and summarization for preparing documents to be submitted to the FDA.
- Requires a high level of skill in strategic thinking and problem solving (for example, when regulatory is preparing an FDA special request related to an investigator initiated study).
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
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