Sr. Specialist, Regulatory Affairs

Orca Bio; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

An innovative biotechnology company is seeking a (Sr.) Regulatory Affairs Specialist to lead regulatory submissions and manage compliance for clinical trials. This role is crucial in shaping regulatory strategies and ensuring alignment with evolving FDA and EMA regulations. Join a passionate team dedicated to redefining the transplant process with cutting-edge cell therapies aimed at improving survival rates for patients battling blood cancer. If you're driven by science and a commitment to patient care, this is a unique opportunity to make a significant impact in the field.

Qualifications

• 3+ years of experience in regulatory affairs supporting clinical trials.
• Knowledge of FDA and EMA regulations and ICH/GCP guidelines.

Responsibilities

• Prepare regulatory documentation for FDA, EMA, and other bodies.
• Participate in defining regulatory strategies for compliance.
• Draft study documents and provide regulatory guidance.

Skills

Regulatory Affairs

Clinical Trials Management

Communication Skills

Organizational Skills

Knowledge of ICH/GCP Guidelines

Education

Bachelor’s Degree in Life Science

Job description

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

As a (Sr.) Regulatory Affairs Specialist (Clinical focus) at Orca Bio, you will play a pivotal role in coordinating Phase 1–3 clinical trials, managing regulatory submissions, and ensuring compliance with FDA, EMA, and other applicable regulations. You will support product registration activities and contribute to defining regulatory strategies that align with both domestic and international legislation. Your expertise will be instrumental in maintaining current awareness of evolving regulations and communicating significant changes to relevant stakeholders.

Responsibilities

• Prepare and process all regulatory documentation for FDA, EMA, and other regulatory bodies, including new submissions, annual reports, amendments, adverse events, and reportable events.
• Participate in defining regulatory strategies that ensure compliance with regulatory standards and align with both domestic and international legislation.
• Actively participate in regulatory and cross-functional team meetings, providing advice and support on regulatory aspects of clinical trials.
• Draft study documents such as protocols, informed consent forms, and case report forms; provide regulatory guidance for investigator-initiated trials and expanded access studies.
• Ensure all study information on ClinicalTrials.gov is current and accurate.
• Maintain awareness of evolving FDA and EMA regulations, communicating significant changes to relevant stakeholders.

Qualifications

• Bachelor’s degree in a life science or adjacent field required.
• Minimum of 3 years of experience in regulatory affairs, supporting clinical trials.
• Preferred experience in oncology and/or cell therapy.
• Knowledge of ICH/GCP guidelines and other relevant regulations.
• Strong verbal and written communication skills.
• Proficiency in organizational, time management, and interpersonal skills.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.