Overview
Reference Number: JO-2309-523431
Regulatory CMC Writer
Rate: Negotiable
Job Type: Permanent
Location: Uxbridge
Regulatory Affairs CMC Project Manager (Writer)
Hybrid or Homebased – UK or Europe
An exciting opportunity to work as a Regulatory Affairs CMC Project Manager for a leading pharma through a leading CRO. The role will support a biologics portfolio and will be responsible for pre-approval CMC activities.
You will be working on global markets and will be accountable for writing regulatory CMC sections at all stages of development. The portfolio will be a mix between biologics and vaccines and ideally would like someone with previous experience in one of these areas.
Key Responsibilities:
- Support regulatory CMC writing activities including authoring CMC sections in development including, CTA, IND, IMPD, MAA, and NDA.
- The position will be focused on CMC and will need a Good understanding of CMC lifecycle maintenance activities across EU and ROW markets.
- Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data.
- Supporting CMC regulatory strategy.
- Prepare and coordinate the review and approval of submission-ready documents.
- Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations.
Experience:
- Previous CRO, Pharma or Regulatory Agency experience is essential.
- Acted in the capacity of Sr Reg Affairs Associate or Consultant level.
- Good Regulatory Affairs experience with a minimum of 3-5 years of CMC regulatory experience – ideally Biologics OR Vaccines.
- Must have previous experience authoring CMC sections.
- Change Control assessment experience (application of relevant regulatory guidance to proposed change).
- Experience working on simple and complex APAC and LATAM submissions would be of benefit.
This is an excellent opportunity to work for a leading organisation and support a large CMC team providing excellent career progression opportunities and a chance to support some leading organisations. The role comes with some excellent benefits including a bonus, life assurance, pension scheme, and private healthcare.
This role does not provide sponsorship and you must have the Right to Work in the UK or Europe. For more details about this position please feel free to contact lucy.kirkaldy@cpl.com
