This client is one of the largest contract manufacturers of biologics in the world. They are seeking a Regulatory CMC Project Manager to provide regulatory support for multiple client projects. In this role you will contribute to global Regulatory CMC strategies for various biologic programs, provide RA consultation and GMP documentation support to a large biologics manufacturing operation, write CMC sections for global applications, and work closely with the biopharma sponsor clients. This is an exciting opportunity to wear many hats and advance your regulatory career at a growing, global organization!
- Contribute to and execute on regulatory CMC strategies for a portfolio of biologic candidates and approved products.
- Conduct post-approval CMC regulatory activities such as change controls, etc.
- Plan, write and review CMC sections for INDs, CTAs, NDAs, amendments, and life-cycle management submissions.
- Work directly with biopharma clients on CMC and project-related matters.
- Provide regulatory support and advice for internal and external customers in line with defined regulatory plans and in response to ad-hoc questions.
- Review and approve technical documentation in support of CMC and QA activities and assess regulatory impact for development process changes.
- Provide insight and guidance on implementation of current regulations with respect to the preparation and submission of CMC regulatory documentation.
- BS in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- 5+ years of experience in Regulatory CMC for pharmaceutical drugs and/or biologics.
- Experience writing and managing CMC sections and post-approval CMC changes.
- Solid knowledge of FDA, EMA and ICH CMC guidelines and regulations and current Good Manufacturing Practices (cGMP).
- Understanding of biologics work processes preferred.
- Expertise in the interpretation and communication of CMC regulatory requirements for site product and process issues.
- Ability to interpret compliance requirements for the creation or review of protocols and site documentation.
- Demonstrated skills managing project timelines.
- Strong organizational skills and attention to detail.
- Excellent verbal and written communication skills.
- Ability to work both independently and in a team environment.
- Strong quality mindset.
- Strong interpersonal skills and ability to interact positively with all functions. High emotional intelligence.