About Rare Disease Research:
As an independent clinical research site, we are 100% dedicated to conducting clinical research, accelerating the development of safe and effective treatments and providing rare disease patients with access to innovative investigational therapies. We are a passionate, caring, multi-disciplinary team conducting clinical research with expertise and compassion, and always to the highest ethical standards.
About This Opportunity:
We are looking for a Regulatory Specialist to join our wonderful team of motivated research professionals. The Regulatory Specialist position plays an important role at Rare Disease Research by helping the team in compliance with regulatory requirements and guidelines governing clinical research studies. The main responsibilities are to assist the team with:
- Compliance Management:
- Monitoring Regulations: Stay up-to-date with relevant regulations, laws, and standards in the industry (e.g., FDA regulations for pharmaceuticals.
- Implementation: Ensure that company policies and procedures are aligned with current regulations and guidelines, assist with the development of SOP and guidance documents as applicable
- Documentation and Reporting:
- Preparation: Develop and maintain accurate records, and documentation such as 1572 required by regulatory bodies.
- Submission: Prepare and submit regulatory filings including but not limited to 1572, ICF to IRB and other relevant regulatory bodies such as FDA
- Regulatory Strategy and Advisory
- Guidance: Provide advice to internal teams on regulatory matters and strategy. Train on SOP, procedure and company's protocols
- Risk Assessment: Evaluate and identify potential regulatory risks and provide solutions to mitigate them.
- Audits and Inspections:
- Preparation: Prepare for and coordinate regulatory audits and inspections with study team, sponsors, and any other entities including but not limited to FDA, IRB and external auditors consultants.
- Follow-up: Address any findings or issues that arise during audits and inspections, ensuring corrective actions are taken.
- Training and Support:
- Training - Conduct training sessions for employees to ensure understanding of regulatory requirements and compliance practices.
- Support - Offer support to different departments on regulatory issues and compliance matters.
- Regulatory Research and Analysis:
- Conduct research to understand new or changing regulations and their implications for the company.
- Analysis: Analyze regulatory trends and provide insights to guide strategic decisions.
- Cross-functional Collaboration
- Coordination: Work closely with other departments (e.g., legal, quality assurance, product development) to ensure that regulatory requirements are integrated into business processes.
- Communication: Act as a liaison between the company and regulatory agencies.
- Compliance Monitoring
- Internal Audits: Perform internal audits to ensure ongoing compliance with regulatory requirements.
- Issue Resolution: Identify and address compliance issues proactively.
- Ethics and Standards
- Integrity: Uphold ethical standards and ensure that all regulatory practices are conducted with integrity and transparency.
The above statements are intended only to describe the general nature of the job, and should not be construed as an all-inclusive list of position responsibilities.
Requirements:
- Bachelor’s or master’s degree in regulatory affairs, life sciences, pharmacy, or a related field.
- 2-3 years experience in clinical research coordination.
- Prior experience in regulatory affairs within the biotechnology or pharmaceutical industry.
- Demonstrated ability to ensure regulatory compliance throughout the lifecycle of clinical research studies, including a strong understanding of relevant regulations (e.g., FDA, EMA, ICH-GCP).
- Proven experience in preparing and submitting various regulatory documents required for clinical trial conduct. This includes the creation and maintenance of Delegation of Authority (DOA) logs to ensure appropriate and documented delegation of study responsibilities to qualified personnel.
- Proven experience with the creation and maintenance of Investigator Site File binders
- Proven experience with IRB submissions and reporting obligations.
- Practical experience in the development and management of comprehensive study start-up packets for clinical trial sites, encompassing essential regulatory documents, study protocols, and informed consent templates.
- Active involvement in quality assurance activities within clinical research, including participation in the planning and execution of internal audits to assess compliance with regulations, guidelines, and internal standard operating procedures.
- Experience in performing thorough quality assurance reviews of critical clinical trial documentation to ensure accuracy, completeness, and adherence to regulatory and procedural requirements.
- Excellent organizational, communication and computer skills
- Attention to detail
- Ability to work independently and collaboratively in a diverse and fast-paced environment
- Please note that due to the immunocompromised nature of our patients, COVID and annual flu vaccinations are required
Job Type: Full-time
Pay: $55,000 - $70,000
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday, fully in-person, onsite
Rare Disease Research is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, or any other characteristic protected by federal, state or local laws.
Notice To Third-Party Agencies:
Rare Disease Research does not accept unsolicited resumes from recruiters or agencies. Any staffing/employment agency, person or entity that submits an unsolicited resume to this site does so with the understanding that the applicant's resume will become the property of Rare Disease Research will have the right to hire that applicant at its discretion and without any fee owed to the submitting staffing/employment agency, person, or entity.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Work Location: In person
Rare Disease Research is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, or any other characteristic protected by federal, state or local laws.
Notice To Third-Party Agencies:
Rare Disease Research does not accept unsolicited resumes from recruiters or agencies. Any staffing/employment agency, person or entity that submits an unsolicited resume to this site does so with the understanding that the applicant's resume will become the property of Rare Disease Research will have the right to hire that applicant at its discretion and without any fee owed to the submitting staffing/employment agency, person, or entity.
Job Type: Full-time
Pay: $55,000.00 - $70,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
