Project Manager, Regulatory Operations Project Management

Aleon Pharma International headquartered in Parsippany, NJ is a global regulatory affairs consulting firm. For more than 14 years, our experienced team has partnered with sponsor companies at the forefront of creating and advancing innovative therapies.

· Inc.’s 2021 Best Workplaces Honoree – National top 3% for employee engagement

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

· 2018 Outstanding Employer Award by New Jersey Business & Industry Association

Job Type: Full-Time

Job Location: Parsippany, NJ (Hybrid WFH)

Job Responsibilities:

• Lead regulatory affairs projects, including pre-IND meetings and other formal meetings with FDA, IND preparation and submission, NDA/BLA preparation and submission, special applications, etc. from project initiation to project completion.

• Communicate directly with all functions at Aleon to develop detailed project plans and timelines to successfully achieve project milestones.

• Support the preparation and review of regulatory documents to be submitted to FDA to ensure the overall quality and compliance with requirements.

• Utilize Aleon’s Asana project management software for streamlining the project management function activities.

• Prepare electronic common technical document (eCTD) submission to FDA.

• Manage Aleon’s Lorenz docuBridge eCTD database.

Qualifications:

• Advanced degree in pharmaceutical / scientific background or Bachelor’s degree with 3 years of pharmaceutical / biotech industry experience in project management.

• We are willing to provide training to exceptional candidates who can demonstrate quality and potential.

Skills and Requirements:

• Excellent organizational, 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, performance-based bonus, 401(k), profit sharing program, health, dental, vision, 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

Equal opportunity employer.

Candidate must be authorized to work in the US.

Job Type: Full-time

Pay: $75,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• On-site gym
• Paid parental leave
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Parsippany, NJ 07054: Relocate before starting work (Required)

Work Location: Hybrid remote in Parsippany, NJ 07054