Vice President, Regulatory Affairs and Quality
Our client is a biotechnology company. They have asked us to assist them in a search for a Vice President of Regulatory Affairs and Quality.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Is responsible for the regulatory and quality strategies as they relate to the development and commercialization of the company’s gene therapy products and establishment and maintenance of the company’s quality systems.
- Acts as primary contact for the FDA, EMA and other health authorities for meetings and applications and strategic lead during the conduct of regulatory inspections. This includes inspection follow-up to assure timely satisfaction of commitments.
- Interacts as needed with IRBs, DSMBs, SABs, international authorities, and any other regulatory or advisory groups to progress programs and inform product development strategy.
- Represents the company during due diligence activities and on oversight committees with corporate partners.
- Represents regulatory and quality interests in association with company Executive Team governance.
- Is responsible for directing the preparation of regulatory submissions (including routine correspondence, INDs, CTAs, BLAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, etc.) in accordance with product development plans and regulatory requirements.
- Is responsible for the implementation and oversight of documentation systems for managing data required for regulatory compliance. This includes documentation for preclinical and animal studies, clinical trials, and associated statistical analyses.
- Evaluates and selects contractors/consultants as necessary to support the preparation of regulatory submissions and routine inspection of company quality systems.
- Develops Regulatory and Quality staff.
- Provides direction for regulatory and quality strategy to staff and project teams, both internally and externally, as required.
- Identifies deficiencies or potential regulatory deficiencies related to product, process, or quality system and lead or coordinate their resolution. Maintains awareness of new and proposed regulatory requirements and assess impact to the company.
- Establishes and maintains practices that are compliant with current regulatory guidance on GLP, GCP and GMP expectations.
- A BS in scientific discipline is required.
- An MS or PhD is preferred.
- At least 12+ years of regulatory affairs management experience (or 10+ years and MS, or 8+ years and PhD).
- Regulatory experience with Clinical Trials is required.
- Requires strong negotiating/problem solving skills.
- Working knowledge of drug submissions and ICH standards, including GLP, GMP and GCP is required.
- Project management of multidisciplined teams in a regulated industry is required.
- Must have a minimum five years direct experience interacting with CBER; preparing and submitting.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.