Director, Regulatory Affairs

Compensation

: $150,470.00 - $150,470.00 /year *

Employment Type

: Full-Time

Industry

: Executive Management




Director, Regulatory Affairs

US-PA-Bala Cynwyd

Job ID: 2
Type: Regular Full-Time
# of Openings: 1
Category: Research & Development
Chondrial Therapeutics

Overview

Chondrial Therapeutics is currently recruiting for a Director of Regulatory Affairs. Chondrial Therapeutics is an emerging biotechnology company focused on the treatment of rare mitochondrial diseases. The Director of Regulatory Affairs is intended to play a key role in the development of the regulatory strategy for all products under development and will be responsible for overseeing the implementation of that plan. The Director is the primary interface with global health authorities, representing the company in such interactions along with relevant business leads. The individual will engage external consultants as appropriate and work alongside internal and external stakeholders to identify potential regulatory risks and issues and appropriate preventative actions and mitigation.



Responsibilities

Job Duties/Responsibilities:

  • Oversee all regulatory submissions and the management of regulatory timelines
  • Serve as the lead on Regulatory submissions to FDA, working closely with the Manager of Regulatory and Quality Operations and external regulatory consultants to manage the submission strategy and plans and to ensure timely submissions
  • Advise project development teams on relevant regulatory requirements
  • Work with the Manager, Regulatory and Quality Operations to catalog and track all regulatory commitments and requirements, interpret such requirements and work with stakeholders to ensure they are met
  • Interface with FDA in FDA meetings, correspondence, and other communications
  • This position requires a close working relationship with subject matter consultants and internal experts to ensure the company maintains regulatory awareness and compliance
  • Maintains ongoing awareness of regulations and guidelines relevant to portfolio and areas of focus
  • Attends relevant FDA meetings to insure up-to-date knowledge of relevant regulations and current industry thinking
  • This role will be responsible for building out the regulatory organization as the company grows and expands its product portfolio



Qualifications

Key Experience, Skills and Knowledge:

  • Minimum of 4-year undergraduate degree
  • Advanced Degree (masters or Ph.D) preferred
  • 10 + years experience in a Regulatory Affairs role in the biotechnology industry
  • Demonstrated success in leading regulatory submissions and approvals including INDs, NDAs, BLAs
  • Knowledge of and experience with regulatory requirements of clinical trials
  • Knowledge of medical affairs functions desirable
  • Experience with regulation of therapeutic proteins by FDA CDER desirable
  • Global Regulatory experience is a plus
  • Understanding of GxP systems and quality principles
  • Demonstrated ability to interpret regulatory requirements into practice and to translate regulatory communications including \"reading between the lines\"
  • Demonstrated ability to work with business leads in a collaborative and supportive role
  • Demonstrated ability to think critically, identify and solve problems
  • Excellent communication, time management and project management skills
  • Continuous quality improvement mindset and attention to details
  • Can do attitude, flexibility, and mental agility

Chondrial Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

PM18


Associated topics: analyst, business, endowment, fundraise, major gift, policy, public, regulatory, relation, solicitation * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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