CEL - Global Regulatory CMC Manager
Global Regulatory CMC Manager
Job Number: 21-02301
Job Number: 21-02301
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Global Regulatory CMC Manager 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!
- Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
- Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
- Responsible for the global regulatory evaluation of CMC change controls with supervision.
- Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
- Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
- Participate in global regulatory interactions with health authorities, with supervision.
- Facilitate document review meetings and discussions.
- Develop and maintain knowledge of regulatory environment, regulations and procedures.
- Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
- Experience in drug development processes and post-approval requirements
- Experience in developing CMC regulatory strategy
- Experience in project management
- Have a solution-oriented approach to problem solving
- Ability to plan/prioritize work of group members and guide/develop others.
- Ability to work on complex projects and within cross-functional teams with supervision
- Excellent communication skills, both written and oral
- Prerequisites BS/BA degree in Scientific Discipline (Masters or higher preferred) with
- 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience
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:
Jane Bautista | 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.