Consultant, Global Regulatory CMC Biologic/Cell Therapy
JobDiva # 20-07497
JobDiva # 20-07497
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Consultant for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Client is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to Client and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture
- The Consultant will be based in Summit, NJ and will assist the Regulatory-CMC Biologics/Cell Therapy team with projects to support department goals and objectives.
- Support Regulatory CMC Biologics & Cell Therapy group in the preparation of submissions.
- Attention to detail, excellent organization skills, good verbal and written communication skills are required.
- Ability to work independently on routine assignments with daily check-ins and to work cooperatively with senior staff providing key assistance on complex assignment.
- Computer experience must include familiarity with Word, Excel and PowerPoint.
- These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.
- Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 5 years of Biologic/Cell Therapy Regulatory CMC experience, including the preparation of Biologic/Cell Therapy CMC dossiers
- At least a bachelors degree required. Masters Degree or PhD preferred
- Extensive experience with Biologic/Cell Therapy CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)
- Experience with CMC regulations for biological compounds
- Experience with Gene/Cell/CAR T Cell therapy CMC regulations
- Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
- Practical knowledge of rest of world post approval guidelines
- Have a solution-oriented approach to problem solving
- Expertise in the drug development process and post approval activities
- Ability to work on complex projects and within cross-functional teams
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Melrose Madrigal | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.