This client is one of the largest contract manufacturers of biologics in the world. Due to a significant expansion at their Portsmouth site, they are seeking a Regulatory CMC Manager (or Sr. Associate) 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 company offers competitive compensation, excellent employee benefits, and a great work/life balance. This is an exciting opportunity to wear many hats and advance your regulatory career at a growing, global organization!
Responsibilities:
- 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, BLAs, 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.
Requirements:
- B.S. in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- 5+ years of experience in Regulatory CMC for pharmaceutical drugs and/or biologics. (3+ years for a Senior Associate).
- 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.
- Ability to understand technical information and interface with scientific personnel.
- Ability to interface with clients at all levels and where necessary, influence their Regulatory Strategy.
- High emotional intelligence.
- Ability to work both independently and in a team environment.
- Strong interpersonal skills and ability to interact positively with all internal functions and with clients.
- Strong organizational skills and attention to detail.
- Excellent verbal and written communication skills.