Job Type: Full-time Location: Washington D.C. Area/New Jersey
Job Responsibilities: • Collaborate with senior management and project teams in the development of regulatory strategies. • Collaborate with the regulatory affairs project teams in the development and preparation, of regulatory applications for innovative drug/biologic products. • Liaise directly with the FDA and possibly other regulatory health authorities. • Plan, prepare for, and attend various formal meetings (Type A, B, C) and teleconferences with the FDA. • Communicate with clients regarding applicable regulatory guidance and scientific advice. • Facilitate regulatory collaborations with outside organizations and regulatory expert consultants. • Evaluate emerging regulations and the evolving global regulatory landscape and provide strategic advice to management and project teams. • Mentor regulatory managers and associates. • Oversee regulatory activities to ensure compliance with regulatory requirements and company SOPs.
Qualifications: • MS/PhD in biological and pharmaceutical sciences or PharmD (PhD or PharmD preferred). • AT LEAST 5 years of direct product review/project management experience required. • Consulting/industry experience preferred but not required.
Skills and Requirements: • Strong organization, communication, and interpersonal skills. • Extensive knowledge of FDA requirements and processes for filing INDs, NDAs, BLAs, etc. • Can-do attitude. • Detail oriented and outstanding analytical skills. • Excellent time management skills.
What We Offer to You: • Countless opportunities to make a difference • Limitless learning opportunities • Friendly and positive work environment that fosters professional growth. • Dynamic company culture focusing on Integrity, Quality and Creativity. • Aleon offers excellent compensation with many benefits, including flexible paid time off, 401(k), profit sharing, full insurance package (health, vision, dental, life, etc.), and much more
We are confident that you will find Aleon has a very rewarding and exciting work environment. If you feel that you are a good fit for this position and our company culture, email your resume with confidence to email@example.com
Winner of the prestigious 2018 Outstanding Employer Award by New Jersey Business & Industry Association.
Contestant for 2020 Inc.’s “Best Workplace Award” in the US (ongoing)
Aleon Pharma International, Inc. is an equal opportunity employer.
Candidate must be authorized to work in the US.
• MS/PhD in biological and pharmaceutical sciences or PharmD (PhD or PharmD preferred). • AT LEAST 5 years of direct product review/project management experience required. • Consulting/industry experience preferred but not required.
Internal Number: 1
About Aleon Pharma International, Inc.
Aleon is a strategic regulatory affairs consulting firm dedicated to helping accelerate our sponsor's novel drug development process. We are specialized and experienced in working with FDA, EMA and NMPA to efficiently guide sponsors through the regulatory pathway.