Associate Director, Regulatory Strategy

Akebia Therapeutics•Cambridge, MA

About The Position

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.

Requirements

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)

Nice To Haves

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

Responsibilities

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.