VP, Regulatory Affairs

Role Summary

The VP of Regulatory Affairs will lead, create and drive the regulatory strategy for lifecycle management activities for Vafseo, Auryxia and early development programs and ensure 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 strengthen the management team, serving as a highly visible, credible regulatory lead, and provide 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 aligned with Akebia’s corporate objectives.

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, ensuring coordination across internal functions and stakeholders.
• Maintain expert knowledge of FDA/EMA regulations and ICH guidelines.
• Provide clear regulatory guidance and direction to other departments and project teams.
• Represent regulatory strategy at project team meetings and provide regulatory support for projects including 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 in the Regulatory Affairs department.
• Develop and implement standard operating procedures and common work practices within the team.
• Host FDA/third party regulatory audits and follow up on findings/observations issued.
• Provide guidance to business development regarding evaluation of potential opportunities in support of strategic partnering and licensing activities.

Qualifications

• Required: 10+ years of progressively responsible experience in drug development and regulatory affairs in biotechnology or pharmaceutical industry; minimum 3 years of leadership experience in a regulatory affairs management role.
• Required: BS degree in a scientific discipline (life sciences or pharmacy preferred); regulatory certification (RAC) a plus.
• Preferred: Advanced degree in biological sciences (MD, PhD, or PharmD).
• Required: Demonstrated knowledge of regulatory aspects of clinical development, including protocol development, data collection/analysis, preparation of INDs and NDAs, and NDA prosecution through FDA/EMA review.
• Preferred: Knowledge of regulatory aspects of drug manufacturing, QA, GCP and GMP compliance.
• Required: Expert knowledge of FDA, EMA and other major regulatory authorities’ regulations and practices.
• Required: Proficiency in regulatory affairs activities including submissions, publishing, review, and oversight; experience negotiating with regulatory agencies (e.g., FDA).
• Preferred: Experience with NDAs and MAAs and gaining global regulatory approvals.
• Required: Strong consulting and analytical skills; ability to balance tactical and strategic issues.
• Required: Demonstrated management expertise and leadership of a Regulatory team; hands-on leader who contributes to regulatory submissions.
• Required: Ability to work independently with excellent organization and attention to detail; strong written and oral communication and presentation skills.
• Required: Ability to work under pressure and meet deadlines.

Skills

• Regulatory strategy development and execution
• Regulatory submissions (INDs, NDAs, MAAs) and lifecycle management
• FDA/EMA interactions and negotiations
• Regulatory operations, CMC, labeling, and advertising and promotion considerations
• Regulatory intelligence and cross-functional collaboration
• Leadership and team development

Education

• Minimum BS degree in life sciences or pharmacy; RAC certification a plus
• Advanced degree (MD, PhD, PharmD) desirable

Additional Requirements

• Location: Cambridge, MA