62 applicants

Company

Original Job Post

Akebia Therapeutics · 5 days ago

Associate Director, Regulatory Operations

United States

Full-time

Remote

Director

$159K/yr - $196K/yr

8+ years exp

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H1B Sponsorship

Comp. & Benefits

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Responsibilities

Manage all regulatory operations activities including but not limited to project submission management, Smartsheet or MS project creation and management.

Work collaboratively with Regulatory Affairs and contributing cross-functional team members to create and maintain regulatory submission project plans, manage deliverable timelines and activities, and works with the Regulatory lead to ensure issues, risks, or impact due to changes in strategy and/ or timelines are assessed quickly throughout the submission process ensuring transparency of submission status to key stakeholders and management.

Track regulatory department information such as commitments with health authorities, contact information, NDA/IND commitments, etc.

Work with an internal partner to manage all submissions and review for OPDP (2253) and SPL submissions.

Act as an expert resource for eCTD submissions to FDA to ensure that documents, datasets, and compiled submissions meet internal and health authority standards in terms of quality, accuracy and compliance.

Maintain expert knowledge of electronic submission and computerized system validation standards.

Support the development and maintenance of operations resources to ensure that submission documents across functional areas meet internal and health authority standards; resources include a style guide, document checklist, and Starting Point Templates

Identify new or revised regulatory policies, processes, and SOPs and initiate activities to support compliance and departmental objectives.

Serve as a primary contact with publishing vendor and other CRO(s) to coordinate activities and processes between external parties and the internal regulatory team and to nurture cooperative and collaborative vendor relationships.

Support vendor selection process, implementation, maintenance and troubleshooting of all regulatory-related information systems and software.

Ensure effective Governance, Support and Change Management for the onboarding and maintenance of the RIMs.

Build and leverage relationships with industry, vendor, and trade associations to influence future regulatory environment from a regulatory operation perspective. Participate in special projects and process improvement initiatives as needed.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory affairsDrug developmentProblem-solvingCommunicationFDA regulations knowledgeCTDECTD structure knowledgeVeeva RIM experienceEDMS experienceVendor managementMicrosoft Office proficiencyProject Management tools proficiencyAdobe Acrobat proficiencyECTD validation tools experienceComplex project leadershipMatrix team environment experienceInterpersonal skillsConflict managementNegotiation skillsDetail-orientedHighly organizedTeam playerOutstanding interpersonal communicationEmbrace core valuesExcitement about vision

Required

Bachelor's degree

8+ years of highly relevant pharmaceutical /biotechnology experience in Regulatory Affairs Operations

Knowledge and understanding of the drug development process

Preferred

Able to display excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory operation strategies

Strong knowledge of FDA regulations, guidelines, and/or specifications (as it applies to Regulatory system activities especially CTD and eCTD structure)

Detail-oriented and highly organized

Knowledge and experience with Veeva RIM or other EDMS

Experience in working with vendors in support of regulatory submissions

Highly proficient in Microsoft Office suite, Project Management tools (Smartsheet), Adobe Acrobat, eCTD validation and viewing tools

Ability to lead complex projects and timelines in a matrix team environment

Strong team player, a professional capable of working collaboratively and independently, with outstanding interpersonal and communication (written and verbal) skills

Embrace Akebia’s core values and culture

Excitement about the vision and mission of Akebia

Benefits

Health care

Vision

Dental

Retirement

PTO

Company

Akebia Therapeutics

Akebia Therapeutics develops treatments for ischemia and vascular diseases.

Founded in 2007

Cambridge, Massachusetts, USA

201-500 employees

http://www.akebia.com

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

Trends of Total Sponsorships

2023 (2)

2022 (2)

2021 (12)

2020 (7)