Akebia is currently expanding its Regulatory team to support late 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 manage high-quality submissions to regulatory agencies through external consultants. 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.
Required Skills
- Propose and design well-informed regulatory strategies for the US and EU for registration and product life cycle activities.
- Represent Regulatory Affairs on project and study sub-teams, especially Clinical and Nonclinical, and provide regulatory guidance to project and study teams
- Leadthe 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.
Required 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
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com
Akebia Therapeutics 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.