Project Manager, Regulatory Affairs Project Management

Website Aleon Pharma International

Aleon Pharma International, Inc. is a strategic regulatory affairs consulting firm. With experienced teams in both the US and China, we work closely with sponsor companies at the forefront of creating new, innovative novel drugs. Using our deep-rooted knowledge and decades of experience and insights working with the Food and Drug Administration (FDA), National Medical Products Administration (NMPA), European Medicines Agency (EMA), and other health authorities, we guide partners through the regulatory maze, so their drug candidates can get to market sooner and more safely.

Are you searching for a rewarding position where you will have extraordinary and fast-track career growth opportunities working for a company that is committed to your success and provides direct training from industry experts and the knowledge you need to succeed? If so, you may be a perfect fit at Aleon!

 

Project Manager, Regulatory Affairs Project Management

Job Type: Full-Time

Job Location: Parsippany, NJ (Temporary work from home due to COVID-19)

 

Job Responsibilities:

  • Manage and take ownership of regulatory projects (including pre-IND meetings and other formal meetings, IND preparation and submission, NDA/BLA preparation and submission, special application projects, etc.) by leading projects from initiation to completion.
  • Communicate directly with Aleon’s clients and other functions at Aleon to develop detailed project plans and timelines to achieve project milestones and project success.
  • Represent Aleon by leading external project meetings with clients.
  • Support the preparation and review of regulatory documents to be submitted to FDA to ensure the overall quality and compliance with requirements.
  • Effectively communicate with FDA project managers regarding specific projects.
  • Implement project management tools / software for the improvement and streamlining of Aleon’s project management function.

 

Qualifications:

  • Masters or PhD in pharmaceutical / scientific background preferred.
  • Experience in project management is required. We are willing to provide training to exceptional candidates who can demonstrate quality and potential.

 

Skills and Requirements:

  • Excellent organization skills.
  • Excellent interpersonal, written, and oral communication skills.
  • Strong desire to learn and ability to thrive in a dynamic and fast-paced environment.
  • Creative and open-minded.
  • Proactive and ambitious.
  • Passionate desire to learn.
  • Excellent time management.
  • Outstanding leadership skills.
  • Ability to set priorities by working with senior management.

 

What We Offer to You:

  • Aleon offers competitive compensation with many benefits, including paid time off, 401(k), profit sharing, health and life insurance, and much more.
  • Aleon has a dynamic and flexible working environment where professionals dedicated to learning can truly thrive.
  • Limitless learning possibilities, and fantastic career advancement opportunities.
  • Friendly and positive work environment.
  • Dynamic company culture where employees are engaged and motivated.

 

We are confident that you will find that Aleon is a very rewarding and exciting place to work. If you feel that you are a good fit for this position, email your resume with confidence to careers@aleonpharma.com.

 

Inc.’s 2021 Best Workplaces Honoree.

Inc.’s 2020 Best Workplaces – National top 5% for employee engagement.

2018 Outstanding Employer Award (1 out of the 3 winners) by New Jersey Business & Industry Association.

Aleon Pharma International, Inc. is an equal opportunity employer.

Candidate must be authorized to work in the US.

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