Associate Regulatory Manager

Associate Regulatory Manager (Hybrid)

The Associate Regulatory Manager oversees and coordinates regulatory activities related to clinical research studies, including quality control and oversight.  

DUTIES & RESPONSIBILITIES

• Maintain a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
• Oversee the preparation, facilitation, and coordination of accurate and timely submission of IRB applications for protocol revisions or amendments, including changes in treatment procedures, administrative changes, subject population, funding, recruitment procedures, site changes, informed consent, or dual enrollment, as required by federal regulations and internal policy.
• Ensure that all documents are complete and that the submission packet meets the IRB's revision submission requirements prior to sending them to the IRB.
• Oversee the communications and responses to queries of the IRB, Sponsor, and other relevant stakeholders due to their review of submissions.
• Coordinate the review, preparation, and submission of consent forms in compliance with regulatory requirements of federal, state, and local agencies governing biomedical research.
• Ensure Sponsor approval of consent forms prior to submission to the IRB, if needed
• Facilitate and coordinate the timely and accurate submission of regulatory documents (hard copies and electronic binders) and IRB submissions by collaborating with relevant cross-functional teams to prepare regulatory documents.
• Ensure that regulatory binders are audited and maintained. Track workload and status of pending protocols and associated supporting documents in order to provide efficient customer service to the Research team.
• Participate in quality assurance (QA) and control programs related to overall project and patient data, including conducting audits and reviews, identifying, and addressing compliance issues, and implementing corrective actions as needed.
• Oversee QA initiatives for the department to support research staff and leaders during sponsor and FDA audits, including conducting internal audits, preparing for external audits, and addressing audit findings.
• Provide guidance and oversight to ensure adherence to quality control processes, including document review, process improvement, and regulatory SOP development.
• Collaborate with cross-functional teams, including Quality Assurance, Clinical Operations, Central Clinical Data, and Data Analytics, to ensure regulatory compliance throughout the study lifecycle.
• Perform any other tasks as assigned by the line manager.

KNOWLEDGE & EXPERIENCE

Education:

• Bachelor's degree in a related field required
• Master’s degree, preferred.

Experience:

• 2+ years of experience in regulatory affairs, preferably in the pharmaceutical or biomedical research industry
• 1+ years with regulatory software, i.e. Florence

Credentials:

• ACRP-CP or the ability to obtain one within 1 year of appointment
• DMCR-required training, including GCP and IATA.

Knowledge and Skills:

• Strong knowledge of FDA regulations, GCP/ICH guidelines, and relevant regulatory requirements.
• Excellent organizational skills with attention to detail.
• Excellent document management skills
• Excellent skills with descriptive processes, procedures, regulations, and guidelines
• Strong communication skills, both written and verbal.
• Ability to work independently and collaboratively in a team environment.
• Proficient in using electronic document management systems and other relevant software.
• Ability to prioritize tasks and manage multiple deadlines.
• Strong leadership and development skills

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