Associate Director/Director, Regulatory Affairs

Location
94560, Newark
Posted
May 19, 2021
Required Education
Bachelors Degree
Position Type
Full time

Job Title: Associate Director/Director, Regulatory Affairs

Reports to: Senior Vice President (SVP), Regulatory Affairs

FLSA Status: Exempt

Department: Regulatory

Company Overview

InCarda Therapeutics, Inc. is a leading clinical-stage biotechnology company located in Newark, CA. InCarda's unique technologies provide transformative capabilities to therapeutic development and the company is advancing an internal pipeline of therapies for managing atrial fibrillation and other related conditions with unmet medical need. InCarda was founded in 2009 and has developed a best-in-class platform with a leading intellectual property position.

PRIMARY RESPONSIBILITY

Candidates for Associate Director/Director, Regulatory Affairs will be responsible to provide regulatory leadership to project teams, and is responsible for managing regulatory activities for assigned projects. These include leadership in the preparation and compilation of regulatory submissions, managing regulatory submission processes and timelines, and collaborating with Regulatory Operations to ensure timely submissions. The candidate will be a direct contact for health authority communications, and will manage the activities of consultants and/or contractors in the performance of the duties outlined below.

The Associate Director/Director, Regulatory Affairs is responsible to perform the following tasks:

  • Work closely with development team members to develop the global regulatory strategy for all cross functional areas including clinical, preclinical, CMC to meet business objectives
  • Manage the creation and maintenance of global regulatory submissions in support of all phases of clinical development
  • Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintaining the highest quality
  • Lead efforts for coordinating content for original INDs, IND amendments, CTAs and NDAs
  • Work with department management on plans for NDA/ MAA submissions and lead preparation and review
  • Take a lead role in preparations for Regulatory Agency meetings including drafting briefing documents
  • Participate in multidisciplinary efforts to prepare updates for regulatory documents including: investigator brochures, annual reports, product labeling, CTA and IND amendments, safety submissions
  • Work with regulatory organizations and partners to prepare applications and respond to queries to enable maintenance of regulatory submissions outside of the United States
  • Establish, manage, and maintain a knowledge base of current and emerging regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues 
  • Ensure communication and alignment on regulatory strategy through partnership and communication with internal key stakeholders, including representing the regulatory department at strategy meetings
  • Assure compliance with regulatory standards and guidance documents
  • Prepare, submit, track, index, and archive electronic submissions
  • Ensure that changes are reported to authorities in accordance with regulatory requirements
  • Conduct regulatory risk assessments of global regulatory issues
  • Liaise with Medical Writing, contract CROs, and Regulatory Operations for coordinating and publishing submission documents
  • Manage regulatory vendors, and contractors
  • Adhere to InCarda Therapeutics, Inc. Employee Handbook

Knowledge, Skill and Competency Requirements:

  • Experience with all stages of the clinical development (IND/ CTA) and registration (NDA/MAA)
  • Experience with regulatory health authority interactions in North America and Europe
  • Experience with drug device combination product development is desirable
  • Knowledge of the drug development process, drug laws, and global regulations and requirements
  • Strong analytical skills, problem solving ability and presentation skills required
  • Flexibility and ability to prioritize and manage multiple tasks simultaneously

·       Demonstrated ability to establish and meet priorities, deadlines, strategic department goals, and objectives

·       Experience in departmental budgeting, organizing, and planning

·       Excellent collaborative skills, ability to work in a start-up environment, and manage change complexity

·       Computer literacy including working knowledge of computer applications such as Word, Excel, and Outlook required 

·       Ability to organize activities and multitask, be performance driven, and possess good decision- making skills

·       Strong verbal and written communication skills.

Education/Experience:

  • B.S. in scientific discipline is preferable with a minimum of 8+ years of regulatory affairs experience is required

Supervisory Responsibilities: 

This position has no current supervisory responsibilities aside from those associated with managing the work of consultants and / or contractors for assigned projects.