Project Manager, CMC Regulatory Affairs

  • Full Time
  • US
  • 12/31/2021

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, CMC Regulatory Affairs

Job Type: Full-time

 

Job Responsibilities:

  • Manage project planning, operation, and reporting of assigned projects.
  • Review Chemistry, Manufacturing and Controls (CMC) documents to assure compliance with FDA requirements and industry standards.
  • Work with CMC management to develop and communicate the regulatory CMC strategy and identify key issues throughout the project.
  • Prepare IND and amendment submissions to the FDA.
  • Keep up to date on FDA regulation and guidance and prepare regulatory analysis report.

 

Qualifications:

  • PhD or Master’s degree in Biochemistry/Molecular Biology or Chemistry (medicinal/pharmaceutical/organic/analytical chemistry or related fields).
  • 1-5 years’ experiences in CMC industry or regulatory affairs preferred. We are willing to train exceptional candidate(s) who can demonstrate quality and potential.

 

Skills and Requirements:

  • Exceptional attention to detail and excellent organization skills.
  • Excellent interpersonal, written, and oral communication skills.
  • Creative and open-minded.
  • Proactive and passionate desire to learn.
  • Excellent time 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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