Associate Director, Regulatory Strategy

Regulatory Affairs

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:

Akebia is currently expanding its Regulatory team to support late and early phase clinical assets and is searching for an Associate Director, Regulatory Affairs. This individual will operate in a high visibility role and will be responsible for representing Regulatory Affairs in cross disciplinary project teams, developing regulatory strategies for assigned program(s), and managing high-quality submissions to regulatory agencies.. As Akebia develops clinical assets there could be additional duties and responsibilities to this role, including the expansion and management of additional team members. This position reports to the Director, Regulatory Affairs.

Essential Functions & Duties:

* Propose and design well-informed global regulatory strategies .

* Represent Regulatory Affairs on project and study sub-teams, especially Clinical and Nonclinical, and provide regulatory guidance to project and study teams

* Lead the preparation for regulatory agency meetings (e.g. pre-IND, End-of Phase 2, Type C, pre-NDA/MAA/NDS)

* Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs, briefing packages.

* Coordinate with project management, subject matter experts and other regulatory functional areas to define content plans and submission logistics and scheduling for on-time delivery of high-quality regulatory submissions to regulatory agencies.

* Assemble and lead teams to develop response strategy to address agency queries and information requests.

* Author regulatory documents to support regulatory submissions.

* Manage and coordinate with selected regulatory CROs for submission of high-quality documents to support ex-US submissions.

* Critically review Investigator Brochures, clinical and nonclinical protocols and study reports, Module 2 summaries

* Review ClinicalTrials.gov and EudraCT postings for supported studies

* Support due diligence activities as assigned; serve as the FDA liaison on new opportunities as assigned

* Establish relevant processes and procedures to support activities of the Regulatory Affairs function and review/liaise with cross-functional departments on company wide SOPs/Work Instructions/initiatives

* Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements.

* Ensure compliance with regulatory requirements and internal standards.

* Manage assigned aspects with development partners and vendors.

* Manage direct reports and mentor regulatory co-ops and interns, as well as provide regulatory guidance to other regulatory staff as needed.

Skills & Experience

Basic Qualifications:

* Bachelor's degree

* Minimum of 8-10 years of pharmaceutical/biotech industry experience with a minimum of 6 years in Regulatory Affairs Strategy (Clinical/Non-clinical related)

Preferred Qualifications:

* Bachelor's degree in life sciences; advanced degree (eg, PharmD, PhD, MD) preferred

* Evidence of successful submissions to FDA (e.g., INDs, briefing packages) and CTAs (ex-US)

* Demonstrated evidence of writing of regulatory documents (e.g., Module 1, Module 2, briefing packages, orphan drug designation applications, pediatric plans)

* Knowledge of FDA and ICH regulations and guidelines a must

* Knowledge of EU regulations and guidelines desirable

* Knowledge of drug development, particularly clinical and nonclinical aspects

* Knowledge of Veeva is helpful

* Excellent written and oral communication skills

* Excellent interpersonal skills

* Strong project management skills and drive for excellence

Compensation:

Targeted Base: *167,425-206,819

*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Are you an Akebian?

An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com

Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law