Careers

JOB SUMMARY  

The Director, Regulatory will oversee Elligo’s Regulatory Department which is responsible for all clinical research regulatory activities across Elligo. The Director of Regulatory is responsible for overseeing the full life cycle of regulatory activities from study start-up to study closure and record retention. This includes, but is not limited to, preparation of regulatory documents required for IRB/IBC approvals, development and maintenance of investigator essential regulatory documents, and coordination of ongoing research monitoring activities.  

RESPONSIBILITIES 

• Foster a culture of regulatory compliance in a collaborative manner aligned with our mission and priorities.  

• Collaborate with senior staff on various regulatory initiatives.  

• Provide leadership and regulatory guidance to staff to ensure all regulatory activities are completed in an efficient, quality driven and timely manner.  

• Provide continuous feedback to business functions to enhance regulatory compliance and improve process.  

• Provide regulatory expertise and guidance to the company.  

• Routinely track and measure the effectiveness and compliance of the team and regulatory function.  

• Serve as a regulatory subject matter expert during customer communications and customer and agency regulatory inspections.  

• Support Computer System Validation (CSV) for regulatory systems.  

• Key stakeholder in Quality Management and Inspection Readiness Programs.  

• Participate in process development initiatives as required. 

QUALIFICATION AND EDUCATION REQUIREMENTS  

• At least 5 years clinical research experience required with at least 3 years of experience in site regulatory matters. 

• BS/BA degree.  Degree in Life Science or related discipline is preferred. 

• Experience in 21 CFR 11 CSV is preferred. 

• At least 2 years in a leadership role.  

• Experience working with or working for local or central IRBs/IBCs is preferred. 

• Data driven, systems thinker who can generate and execute ideas at strategic and tactical levels. Thrives in a fast‐paced environment, integrating disparate activities, new technologies, and agendas while adhering to deadlines and budgets.  

• Instinctive collaborator with strong staff management experience who values teamwork and the input of others.  

• Strong analytical and problem-solving skills with the ability to understand the big picture.  

• Strong computer skills including Microsoft Office applications; Internet and technology savvy.  

• Confirmed proficiency with word processing, spreadsheet, database and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint.)  

WORKING CONDITIONS 

If the candidate is located in our Austin office, this job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.  

If the candidate works remotely from home, the role routinely uses standard office equipment such as computers, phones, and photocopiers. 

WORKING SCHEDULE 

Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand. 

TRAVEL REQUIREMENTS 

Infrequent (<10%) travel is required for this position. If the position is remote, this may require more travel. 

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel.  More in-depth information can be found in SOP's, working guidelines, policies, etc. 

Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.