Regulatory Affairs Manager

Job Description

• Prepare and review various modules of ANDAs, NDAs, and responses to FDA queries.
• Devise strategy and review Meeting Packages and Proprietary Name requests with limited supervision for NDA’s.
• In-depth knowledge and experience of regulatory CMC documents review, and approval is required.
• Provide regulatory guidance to cross functional teams on product development, manufacturing, testing and commercialization of various complex drug products and dosage forms.
• Stay current and proactively implement new regulations published by the US FDA
• Establish and maintain effective internal and cross-functional team communications i.e. provide regular feedback and communicate work challenges/issues and successes.
• Maintenance of Electronic Submissions Gateway account and eCTD software
• eCTD compilation experience is preferred.
• Any other work assigned by the supervisor.
  
  

Requirements and Qualifications:

• Bachelor’s degree with 8 plus years’ experience in regulatory strategy and filing of ANDA’s, New Drug Applications (NDA) in a pharmaceutical Industry.
• Hands on experience of using any e-CTD build software.
• Ability to multi-task in a fast-paced environment with minimal supervision.
• Ability to work flexibly, organize own workload and effectively manage competing priorities.
• Excellent attention to detail and accuracy maintaining consistently high-quality standards.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Willingness to learn new skills and flexibility to support business needs
• Apply knowledge and expertise, to contribute to and provide solutions to process improvements.
  
  

Company Description

Ingenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.

Ingenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.