VP Regulatory Affairs & Quality Assurance – Atlanta Area Pharmaceutical Research and Development
VP Regulatory Affairs and Quality Assurance
My client is a very small pharmaceutical research and development company located in Georgia and is focused on the development of innovative drug products targeted to unmet medical needs, especially in indications where orphan drug exclusivity and patent protection are high potentials. This company finds and researches pharmaceutical products and assists their partners in bringing them to market and helps get their product ideas approved.
They have been in business since the early 90’s and are employee owned. The employee/owners have over 200 years of combined experience in formulation development, analytical services, manufacturing, clinical and regulatory affairs, consulting and project management for pharmaceutical products. They develop and out-license IP for differentiated 505(b)(2) NDA drug products. They find and research pharmaceutical product ideas and assist their partners in bringing them to market.
As an ESOP, their culture is unique. It’s entrepreneurial, it’s transparent, it’s like a family, it’s one of accountability. Everyone is invested in the success of this company!
Due to growth, they are in need of a VP Regulatory Affairs and Quality Assurance to join them. This position is part of the organization’s Leadership Team.
- 10+ years of Pharmaceutical Regulatory and Quality experience in progressive leadership positions
- Experience with validated electronic submissions software
- Strong knowledge of FDA requirements relating to regulatory submissions (INDs and NDAs) and clinical investigations
- Good cGMP compliance background
- Must be willing to live in the Atlanta area (some relo provided)
The VP, Regulatory Affairs and Quality Assurance, a newly created position, is a hands-on leader responsible for driving all regulatory and quality activities within the Company, including development and implementation of regulatory strategies aligned with the company’s vision and securing the approval of high-quality pharmaceutical products. This key role establishes a quality culture by providing guidance, strategic insight, and counsel to the company’s leadership team and research & development regarding guidelines on global regulatory and quality matters, ensuring the timely preparation of regulatory submissions and compliance in all aspects of quality systems. This individual will lead interactions and represent the Company with CMOs, CROs, and appropriate regulatory agencies worldwide. S/he will further define, shape, and build the expanded resources and systems anticipated within regulatory and quality to support growth and commercialization. This is a fantastic opportunity to be a leader in establishing new and exciting products within regulated landscapes.
- Lead regulatory strategy, submissions, product registrations, clearance/approval, commercialization, post-market regulation, and quality systems for the company’s technology driven products
- Be responsible for building the regulatory rollout strategy, interfacing with the regulatory agencies, and executing submissions in the US and other markets
- Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies, setting the standards for, and reviewing all FDA submission and foreign filings to ensure timely and complete submissions
- Provide interpretive guidance on regulatory requirements for all product development projects
- Evaluate the impact of regulatory changes to existing products and recommend strategies to facilitate the transition, communicating impact to management
- Maintain and prepare, as appropriate, regulatory affairs files such as technical files, product listings, certificates, licenses, etc.
- Monitor regulations for each market and manage communications with each regulatory body to ensure compliance
- Review labeling, advertising, sales support, marketing literature, and training materials for regulatory compliance – collaborating with the commercial organization regarding statements and claims made regarding the company’s products
- Design, implement, and manage a quality management system for the company which can scale and flex as the company grows – activities include establishing a CAPA program, complaint handling, risk management, statistical techniques program, training program and internal and external auditing
- Guide the company’s leadership teams with regard to adhering to quality metrics in order to allow for submissions
- Perform thorough risk analyses on a regular basis, communicate findings with company leadership, and collaboratively develop risk management plan reflective of findings
- Plan, prepare, and oversee internal and external audits
- Serve as the Company’s representative with the FDA and notified bodies; negotiate regarding product approval strategies, submissions, and surveillance activities
- Ten plus years of regulatory and quality experience in progressive leadership positions; experience with validated electronic submissions software, statistical analytics, and cGMP/cGCP is ideal. A strong knowledge of FDA requirements relating to regulatory submissions and clinical investigations is required
- Demonstrated success in the development and execution of regulatory efforts, both domestic and international regulatory experience with the ability to interpret FDA and international guidelines and regulations, anticipate federal regulatory concerns, and integrated regulatory requirements into development programs at an early stage
- An understanding and expertise regarding the true requirements to get a pharmaceutical product through the testing/validation, review, and approval process in an expeditious manner
- Strong managerial experience, capable of setting direction for a team of regulatory and quality staff, while working in the rigors of a fast-paced environment
- Excellent project planning, project management, negotiation, and presentation skills
- Proven leadership in compliance with an ability to troubleshoot within FDA and international regulations and guidelines including, but not limited to clinical strategy, GCPs, GLPs, SOPs, submissions, product launch, labeling, advertising, promotion, product vigilance, and reporting
- Have a background of a respected quality executive in the industry and have an excellent working relationship with the FDA. Strong ability to navigate changing political environments as necessary
- Significant experience relating to marketing and business issues with a focus on regulatory support of commercial assets
- Strong knowledge of both domestic and international laws and regulations
- High-level analytical skills and ability to focus on detail
- Demonstrated comfort working in a dynamic, entrepreneurial environment where strong organizational, leadership, and communication skills were required to be successful
- Past experience working for the FDA is a plus