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Director, Regulatory Strategy

Company: SilkRoad
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: CASSS

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Akebia is currently expanding its Regulatory team to support ofclinical development and is searching for a Director, RegulatoryAffairs to support programs across all phases of development. Thisindividual will operate in a high visibility role and will beresponsible for developing and coordinating regulatory strategiesand leading INDs/CTAs, Health Authority Meetings, NDA/MAAs andpost-approval/life cycle management strategies. In this position,they will partner with cross-functional teams to supportprograms.

Design and support implementation of well-informed globalregulatory strategies

Represent Regulatory Affairs on project sub-teams and provideregulatory guidance (e.g., protocol reviews, report reviews,development plans)

Support and lead in the preparation of meetings with RegulatoryHealth Authorities (e.g. U.S., E.U, Japan)

Lead in the coordination, preparation and timely submission ofregulatory documents (e.g. INDs, MAAs, NDAs).

Manage regulatory aspects for clinical studies

Manage, mentor, and develop direct reports

Write regulatory documents to support regulatory agencysubmissions

Coordinate with external publishing resources for on-timedelivery of high-quality regulatory submissions to regulatoryagencies

Establish relevant processes and procedures to support theRegulatory Affairs function activities

Participate in regulatory intelligence gathering activities andmaintain knowledge of US, EU and ROW regulatory requirements

Ensure compliance with regulatory requirements

Requirements

Basic Qualifications:

Minimum of 8 years pharmaceutical industry experience with aminimum of 5 years in Regulatory Affairs

Specific experience working on a successful NDA and/or MAA

Experience managing and developing direct reports

Preferred Qualifications:

Bachelor's degree in life sciences discipline

Advanced degree

Leading preparation of an NDA and MAA strongly preferred

Evidence of successful submissions to FDA and EMA (e.g. IND,NDA, MAA, briefing packages)

Demonstrated evidence of writing regulatory documents (Module 1,Module 2, briefing packages)

Knowledge of US and EU regulatory requirements

Knowledge of drug development

Excellent written and oral communication skills

Excellent interpersonal skills

Strong project management skills and drive for excellence

Akebia Therapeutics, Inc. is a fully integratedbiopharmaceutical company focused on the development andcommercialization of therapeutics for people living with kidneydisease. The Company was founded in 2007 and is headquartered inCambridge, Massachusetts. For more information, please visit ourwebsite atwww.akebia.com

Akebia Therapeutics is an equal opportunity employer andwelcomes all job applicants. All qualified applicants will receiveconsideration for employment without discrimination on the basis ofrace, color, religion, sex, sexual orientation, gender identity,national origin, protected veteran status, disability, or any otherfactors prohibited by law.

Job Information

Job ID: 54142435

Location:

Cambridge, Massachusetts, United States

Position Title: Director, Regulatory Strategy

Company Name: Akebia Therapeutics

Job Function: Regulatory

Job Type: Full-Time

Job Duration: Indefinite

Min Education: BA/BS/Undergraduate

Min Experience: 5-7 Years

Required Travel: 10-25%

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Keywords: SilkRoad, Cambridge , Director, Regulatory Strategy, Other , Cambridge, Massachusetts

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