What are the responsibilities and job description for the Senior Regulatory Specialist position at Lifelancer?
About the job Senior Regulatory Specialist
Job Title : Senior Regulatory Specialist
Job Location : United States
Job Location Type : Remote
Job Contract Type : Full-time
Job Seniority Level : Mid-Senior level
What We Do Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are We care. Our people are the engines behind our mission : to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview The Senior Regulatory Specialist will oversee all details of regulatory for assigned trials for both the traditional and decentralized site models and is responsible for ensuring compliance with regulations and supporting start up activities for all sites and studies.
What You'll Be Working On (Duties include but are not limited to) :
- Develop and execute regulatory strategies to obtain and maintain regulatory approvals for Care Access projects
- Lead communications and serve as main contact with regulatory bodies
- Develop, review, and submit high-quality and timely regulatory agency submission materials, including but not limited to protocols, ICFs and marketing materials
- Stay updated on evolving regulations, guidelines, and industry best practices to ensure compliance and adjust strategies
- Collaborate closely with cross functional teams, including, but not limited to senior leadership, patient marketing and study operations
- Track essential documents and timelines
- Handling submissions to the IRB, management of essential regulatory documents
- Maintain centralized document storage
- Ensure quality is maintained in all investigator site files for assigned studies
- Support sites through their evaluation and begin start-up activities upon selection
- Support the site through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout
- Support audits and monitoring visits to ensure regulatory compliance
- Oversee activities throughout the duration of the study; supporting clinical operations teams as required
- Review study information and understand start-up timelines, requirements, key contacts, and performance expectations
- Actively work towards KPIs to help ensure departmental success
- Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines
- Work with department head on new initiatives and projects to help grow department
- Display high level of integrity and professionalism
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
Physical And Travel Requirements
What You Bring (Knowledge, Skills, And Abilities)
Certifications / Licenses, Education, And Experience
Benefits (US Full-Time Employees Only)
Diversity & Inclusion We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
Lifelancer ( https : / / lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https : / / lifelancer.com / jobs / view / ab1373201c8ddb79be1e609ba91009a8
