Regulatory Affairs Consultant (CMC vaccines)

A Regulatory Affairs Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting provides. A Regulatory Affairs Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Regulatory Affairs Consultant assures the work of the entire team is delivered on time and that it meets client’s quality expectations.

We are currently looking for a Regulatory Affairs Consultant who will have the following responsibilities: Develop submission plans and contribute to the execution of timely and innovative regulatory strategies in support of global development and life cycle management of assigned projects 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 global Clinical Trial Applications, 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 copyediting check Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data QualificationsIdeal candidate will possess: BA/BS in 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 probability of regulatory success and regulatory compliance Experience preparing CMC sections of INDs, NDAs, and supportive amendments and supplements (ICH Modules 2 and/or 3) Thorough understanding of change management processes and regulatory requirements Strong problem solving and diplomacy skills Exposure to regulatory requirements for biologic product development is highly desired Excellent project management skills Fluent English