Senior Regulatory Affairs Associate- CMC Writer (Vaccines)

Parexel are currently seeking an experienced CMC Writer to work hand in hand with our key client from the biopharma industry. An ideal candidate will have experience in vaccines/ biologics domain. This opportunity is available in a number of European countries home or office-based.

As a Regulatory Consultant, CMC Writer, you will: Collaborate with Global RA CMC lead and/or Regional RA CMC lead to provide regulatory support for assigned projects Communicate with Regulatory Operations on the planning of marketing applications and post-approval supplements and variations Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA) 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 Review submission documents to ensure messaging is clear and consistent within and across documents, and to perform a final copy/editing check Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data QualificationsBA/BS in a scientific or technical discipline or advanced degree At least 3-5 years of biopharmaceutical regulatory experience Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance the probability of regulatory success and regulatory compliance Experience preparing CMC sections of INDs, NDAs, and supportive amendments and supplements (ICH Modules 2 and 3) Thorough understanding of change management processes and regulatory requirements Strong problem solving and diplomacy skills Exposure to regulatory requirements for vaccine/biologic product development is highly desired Excellent project management skills Fluent English