Project Manager, Regulatory Affairs Project Management

Aleon Pharma International headquartered in Parsippany, NJ is a global regulatory affairs consulting firm. For more than 12 years, our experienced regulatory professionals have 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:

• Manage regulatory 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 FDA project managers and represent the company in formal meetings with FDA (Type A, B, C, D, etc.)
• Communicate directly with all functional teams 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 Asana project management software for streamlining the project management function activities.
• Develop/update internal guidelines/guidances including pre-IND meetings and other formal meetings with FDA, IND preparation and submission, NDA/BLA preparation and submission, special applications, etc. based on changes from FDA.

Qualifications:

• Pharm.D. or Master’s degree in pharmaceutical / scientific background or Bachelor’s degree with at-least 2 years of pharmaceutical / biotech industry or research experience 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.
• Effectively lead informal/formal meetings or training sessions.
• 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.
• Excellent collaboration.
• Ability to set priorities by working with senior management.
• Proficiency in Microsoft Office Suite (especially in Word and Excel).

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: $70,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Parsippany, NJ 07054: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA regulations: 1 year (Preferred)

Work Location: Hybrid remote in Parsippany, NJ 07054

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