VP, Regulatory Affairs

Akebia Therapeutics•Cambridge, MA

6d•$307,913 - $380,363

About The Position

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary The VP of Regulatory Affairs will lead, create and drive the regulatory strategy for life cycle management activities for Vafseo, Auryxia 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, Regulatory Affairs will further strengthen the management team, serving as a highly visible, credible regulatory lead, and bring strong leadership to the development organization. Reporting to the Head of Research and Development/Chief Medical Officer, this individual will lead the Regulatory team which covers five main areas, Regulatory Strategy, Regulatory CMC, Regulatory Operations, Regulatory Intelligence, and Regulatory Labeling and Advertising and Promotion. This person will be a member of the Research and Development Leadership team and accountable for delivering Regulatory Strategy and Operational excellence, that is aligned with Akebia’s overall corporate objectives.

Requirements

10+ years of progressively responsible experience in drug development and regulatory affairs in the biotechnology or pharmaceutical industry.
The position also requires a minimum of 3 years of leadership experience in a regulatory affairs management role.
Minimum BS degree in a scientific discipline, preferably life sciences or pharmacy; regulatory certification (RAC) a plus.
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
Proficient in the delivery and conduct of all Regulatory Affairs activities including, but not limited to: submissions, publishing, review, and oversight
Demonstrated experience in negotiating with and presenting to regulatory agencies such as FDA.
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

Nice To Haves

An advanced degree in the biological sciences (MD, PhD, or PharmD) is desirable.
Prior experience of NDAs and MAAs and gaining global regulatory approvals is desirable.

Responsibilities

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
Foster strong relationships and advocacy with FDA and international regulatory authorities as well as ensuring strong coordination and collaboration across internal functional and stakeholders
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
Provide guidance to business development regarding critical evaluation of potential opportunities in support of strategic partnering and licensing activities