Akebia Therapeutics · 2 hours ago
Associate Director Regulatory Labeling
Cambridge, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$166K/yr - $204K/yr
7+ years expAkebia Therapeutics is dedicated to improving the lives of those affected by Chronic Kidney Disease. The Associate Director Regulatory Affairs, Labeling is responsible for leading cross-functional teams for labeling activities and ensuring compliance with regulatory agency requirements while meeting strategic labeling objectives.
BiotechnologyHealth CareTherapeutics
Responsibilities
Plans and manages USPI and CCDS creation, maintenance, distribution, tracking and implementation to ensure documents are produced in a timely manner according to internal operating procedures and external regulatory requirements
Regulatory lead for the development and lifecycle management of product labeling and artwork (new and revised), with a cross-functional team, ensuring all labeling/artwork is compliant with labeling regulations and Akebia quality standards
Identifies and provides guidance on the development, or improvement, of policies, processes, and standards for labeling activities
Maintains a deep and current awareness of evolving FDA, and key international labeling regulations, advisory comments, enforcement actions and policy issues
Monitors US and key international labeling for competitor updates and keep the organization up-to-date
Responsible for drug listing of original and revised SPLs to support U.S. commercial launch and post-marketing activities
Responsible for the maintenance of SPL software database to track the history and version control of each SPL
Qualification
Required
BA/BS Degree
A minimum of 7 years of pharmaceutical industry experience, with at least 3 years of regulatory affairs experience focused labeling for prescription drug products
Preferred
Advanced degree (MS, PhD, PharmD, or JD)
Experience with launching new products and/or new indications
Strong interpersonal and oral and written communication skills
Able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate
Solid understanding of FDA labeling regulations
Demonstrated ability to influence others and foster team collaboration
Strong interpersonal, communication and leadership skills
Forward thinker with strong industry knowledge and ability to identify, synthesize and act upon strategic information and changes within the environment
Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of backgrounds and disciplines
Demonstrated decision-making and problem-solving capability; ability to negotiate skillfully to achieve a fair outcome or promote a common cause
Benefits
Health care
Vision
Dental
Retirement
PTO
Company
Akebia Therapeutics
Akebia Therapeutics develops treatments for ischemia and vascular diseases.
201-500 employees
H1B Sponsorship
Akebia Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (5)
2023 (3)
2022 (12)
2021 (4)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$442.5M2024-01-30Post Ipo Debt· $37M
2020-05-11Post Ipo Equity· $151.8M
2019-11-12Post Ipo Debt· $100M
Leadership Team
John Butler
President and CEO
Erik Ostrowski
CBO & CFO
Recent News
2025-12-04
globallegalchronicle.com
2025-12-03
2025-12-02
Company data provided by crunchbase