My client is an innovative biotechnology company that uses its technology to identify unique disease targets and design effective first-in-class antibody-based therapeutics. Our company offers a new approach to the well- established pharmaceutical market for complex diseases, with the ability to identify new targets and engineer novel antibodies to be broadly effective in combating complex diseases with growing global unmet medical needs. Our exciting pipeline includes a human monoclonal antibody designed to offer truly broad-spectrum treatment of influenza A that is currently in clinical trials. Also, a monoclonal antibody to treat all four serotypes of dengue virus and is expected to enter the clinic soon; and multiple other interesting infectious and non-infectious disease targets.
The Senior Vice president, Regulatory Affairs is responsible for is responsible for developing and oversee strategic approaches to ensure that the company's developmental products meet regulatory agency requirements and industry current practices both nationally and internationally. In addition, the Quality group responsible for oversight of the companies GXP activities reports to this position.
- Serve as the primary Regulatory-CMC representative and leader on project teams and committees, including leading meetings with regulatory agencies for all CMC-related matters (i.e., briefing document development, slide development, meeting coordination, team preparedness and response)
- Provide strategic and tactical CMC regulatory guidance for global development and registration programs (i.e., IND, CTA, NDA, MAA), working closely within the CMC teams to plan, integrate and align global regulatory expectations for development and commercialization
- Manage timelines & lead the compilation, review, and approval process of CMC documents intended for regulatory submission. Manage CMC submissions, including writing, QC, and formatting of appropriate sections of IND/IMPD and marketing application sections, including responses to regulatory agency requests for information, working collaboratively with subject matter experts in CMC tech ops, QA, global supply chain and other functions, as needed to ensure alignment of submission components
- Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable global regulations and guidelines
- Manage and ensure compliance with all CMC reporting requirements, including management of the CMC change control process, tracking of global regulatory commitments, annual reports.
- Manage consultants, contract staff and vendors, as needed to support regulatory activities
- Requires a doctorate degree (PhD, MD) and demonstrated senior leadership experience or a bachelor's degree and 15 years' experience including senior management experience. Prior experience as a senior leader of regulatory affairs for a Biologics Manufacturing organization is required.
- Demonstrated ability to effectively manage: processes, others, performance, and set and prioritize departmental goals
- Excellent time management and organizational skills demonstrated ability to manage and prioritize multiple teams, multiple projects and meet deadlines
- Excellent written and verbal communication skills
- Excellent customer service skills
- Experience in any of the following areas preferred: IND submissions, BLA submissions and submissions to regulatory agencies in other countries
- May require national and international travel