Head of Regulatory Affairs

Position: Head of Regulatory Affairs
Location: Cambridge, MA or remotely based anywhere in the US
Reporting to: Chief Medical Officer

Our client is a well-funded, clinical-stage neuroscience biopharmaceutical company developing several different diagnostic and therapeutic platforms to detect and target neurodegenerative disease pathologies, leveraging both small molecules and biologics. They are currently advancing the first of their best-in-class non-invasive diagnostics (PET) tracers that target pathological protein aggregates for neurodegenerative diseases, including Alzheimer’s Disease and Parkinson’s Disease.

•  Their therapeutic programs (including both small molecules and biologics), have lead candidates discovered through screening platforms to precisely neutralize the pathological protein aggregates.
• Their small molecule programs have identified compounds that either switch the balance from toxic aggregates to native forms (modulators) or remove distinct protein aggregates (degraders).
• Their lead antibodies can block toxic protein aggregates in the extracellular space and stop their spread to slow or even prevent disease progression.

We are working with them to identify an experienced executive for a Head of Regulatory Affairs. This key leadership position will support all RA related activities required to progress their novel programs through preclinical and clinical development and to ensure alignment within the company and regulatory agencies.

This individual will be responsible for representing Regulatory Affairs in cross disciplinary areas and manage high-quality submissions to regulatory agencies. As Aprinoia develops clinical assets, there could be additional duties and responsibilities to this role, including the expansion and management of additional team members.

Responsibilities

• Represent Regulatory Affairs on project sub teams, especially Clinical and Nonclinical
• Provide regulatory strategy and guidance for teams (e.g., protocol reviews, report reviews, development plans)
•  Responsible for preparing for regulatory agency meetings (e.g., Pre-IND, Type A, B & C, Pre- NDA/MAA/NDS, etc.)
• Prepare regulatory submissions including but not limited to INDs, CTAs, annual reports, NDAs, MAAs, briefing packages as well as orphan drug designation documents
• Write regulatory documents to support regulatory submissions
•  Interacts with regulatory agencies
•  Develop and implement strategy for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc.
•  Provide expertise in translating regulatory requirements into practical, workable plans.
•  Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
•  Establish and maintain Clinical Trials.gov postings for supported studies
• Participate in regulatory intelligence gathering activities and maintain knowledge of US and APAC regulatory requirements
• Ensure compliance with regulatory requirements and timely preparation of organized and scientifically valid applications.

 

Qualifications and Experience

• Bachelor’s degree in life sciences required; advanced degree preferred
•  Minimum of 10 years in Regulatory Affairs
•  Experience with the Neurology division of FDA is a plus.
  Experience with ex- USA regulatory authorities, e.g. APAC, is a plus.
• Experience as the lead regulator on BLA’s & NDA’s
•  Evidence of successful submissions to FDA (e.g., INDs, briefing packages)
•  Demonstrated evidence of writing of regulatory documents (e.g. eCTD Module 1, Module 2, briefing packages, etc.)
•  Knowledge of FDA, and ICH regulations and guidelines a must
•  Knowledge of APAC regulations and guidelines a plus
•  Knowledge of drug development, early through late stagea must
•  Excellent written and oral communication skills
• Excellent interpersonal skills
•  Strong project management skills and drive for excellence

COMPENSATION
An attractive compensation package commensurate