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Licensed Practical Nurse

Akebia Therapeutics

Licensed Practical Nurse

Cambridge, MA
Full Time
Paid
  • Responsibilities

    Akebia is currently expanding its Regulatory team to support late phase clinical assets and is searching for an Senior Regulatory Affairs Manager.  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
    • Provides oversight to ensure regulatory compliance of marketed products
    • This person may also play a lead role in filing new INDs
    • Represent Regulatory Affairs on project and study sub-teams, especially Clinical and Nonclinical, and provide regulatory guidance to project and study teams (e.g. protocol reviews, report reviews, development plans)
    • Assist in the preparation and participate in regulatory agency meetings (e.g. pre-IND, End-of-Phase 2, Type C, pre-NDA/sNDA/MAA/NDS)
    • Lead the preparation of regulatory submissions which may include INDs, CTAs, annual reports, NDA/sNDA, MAAs, briefing packages
    • Work with cross-functional teams to define contributions to submissions
    • 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
    • Review ClinicalTrials.gov postings for supported studies
    • Establish relevant processes and procedures to support activities of the Regulatory Affairs function
    • Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements
    • Ensure compliance with regulatory requirements and internal standards.
    • Collaborate with development partners and vendors for regulatory alignment
    • Perform regulatory due diligence assessments for new business opportunities as appropriate
    • Mentor regulatory co-ops and interns and provide guidance to junior regulatory staff as needed.

    Required Experience

    Basic Qualifications:

    • Bachelor’s degree 
    • Minimum of 7 years of pharmaceutical/biotech industry experience with a minimum of 5 years in Regulatory Affairs Strategy (Clinical/Non-clinical related)

    Preferred Qualifications:

    • Bachelor degree in Life Sciences
    • Advanced degree (eg, PharmD, PhD, MD) preferred
    • Experience in preparing major regulatory submissions and supportive amendments or supplements
    • 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
    • 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.

     

  • Qualifications
    • Propose and design well-informed regulatory strategies for the US and EU for registration and product life cycle activities
    • Provides oversight to ensure regulatory compliance of marketed products
    • This person may also play a lead role in filing new INDs
    • Represent Regulatory Affairs on project and study sub-teams, especially Clinical and Nonclinical, and provide regulatory guidance to project and study teams (e.g. protocol reviews, report reviews, development plans)
    • Assist in the preparation and participate in regulatory agency meetings (e.g. pre-IND, End-of-Phase 2, Type C, pre-NDA/sNDA/MAA/NDS)
    • Lead the preparation of regulatory submissions which may include INDs, CTAs, annual reports, NDA/sNDA, MAAs, briefing packages
    • Work with cross-functional teams to define contributions to submissions
    • 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
    • Review ClinicalTrials.gov postings for supported studies
    • Establish relevant processes and procedures to support activities of the Regulatory Affairs function
    • Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements
    • Ensure compliance with regulatory requirements and internal standards.
    • Collaborate with development partners and vendors for regulatory alignment
    • Perform regulatory due diligence assessments for new business opportunities as appropriate
    • Mentor regulatory co-ops and interns and provide guidance to junior regulatory staff as needed.
  • Industry
    Transportation / Trucking / Railroad