Akebia Therapeutics is a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia inducible factor, or HIF, biology and the commercialization of these products for patients with kidney disease. We are developing our lead product candidate, vadadustat for the treatment of anemia secondary to CKD. The global program is currently in Phase 3 development. Additionally, we have pre-clinical stage candidates that are being evaluated for a number of potential indications.
The VP of Regulatory Affairs will lead, create and drive the regulatory strategy for vadadustat and early development programs and ensure that there is a sound regulatory foundation for the successful advancement of the products through development and ultimately well positioned for rapid global regulatory approval. The VP will have primary responsibility for regulatory strategy, regulatory interactions, and submissions, both domestically and globally. The VP will also play a leadership role providing management and guidance across the function.
- Formulate and oversee implementation of regulatory strategy and activities needed to secure approval of Akebia's products.
- Manage coordination, preparation and timely submission of regulatory documents (e.g., INDs, MAAs, NDAs).
- Author, review and critique documents that will be included in regulatory applications and interactions
- Maintain expert knowledge of, and familiarity with, FDA/EMA regulations and ICH guidelines.
- Provide clear and valid regulatory guidance and direction to other departments and project teams.
- Represent regulatory strategy at project team meetings and provide regulatory support for projects which may include clinical, preclinical, CMC and marketing issues.
- Develop and maintain relationships with external vendors and health care regulatory authorities.
- Manage all activities pertaining to interactions with FDA, and other health care regulatory authorities, and communicate outcomes to senior management.
- Supervise team members and consultants to the Regulatory Affairs department.
- Develop and implement standard operating procedures and common work practices within the team.
- Host FDA/third party regulatory audits and ensure follow up on findings/observations issued
- Foster strong relationships and advocacy with FDA and international regulatory authorities as well as ensuring strong coordination and collaboration across internal functional and stakeholders
- Provide guidance to business development regarding critical evaluation of potential opportunities in support of strategic partnering and licensing activities
- Minimum BS degree in a scientific discipline, preferably life sciences or pharmacy; regulatory certification (RAC) a plus.
- 10+ years of progressively responsible experience in drug development and regulatory affairs in the biotechnology or pharmaceutical industry.
- 3 years of leadership experience in a regulatory affairs management role.
- An advanced degree in the biological sciences (MD, PhD, or PharmD).
- Demonstrated knowledge in the regulatory aspects of clinical development, including protocol development, data collection and analysis, preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA), and prosecution of NDAs through review to a final decision by health care regulatory authorities, specifically including FDA and EMA.
- Knowledge and management of the regulatory aspects of drug manufacturing, quality assurance, and GCP and GMP compliance is a strong plus.
- Demonstrated expert knowledge of the regulations and practices of FDA, EMA, and other major health care regulatory authorities
- Demonstrated experience in negotiating with and presenting to regulatory agencies such as FDA.
- Prior experience of NDAs and MAAs and gaining global regulatory approvals is desirable.
- Strong consulting and analytical skills and the ability to understand, balance, and articulate both tactical and strategic issues and solutions
- Demonstrated management expertise, including the leadership and professional development of the Regulatory team.
- A hands-on leader who leads by example as well as willingness to roll-up sleeves and draft sections for regulatory submissions.
- Demonstrated ability to work independently with exceptional organization and attention to detail.
- Excellent oral and written communication and presentation skills.
- Ability to work well under pressure and adhere to deadlines
- Proficient in the delivery and conduct of all Regulatory Affairs activities including, but not limited to: submissions, publishing, review, and oversight