Senior Regulatory Affairs Associate/Consultant - CMC (vaccines)

AMAZING OPPORTUNITY TO PARTNER WITH AN INNOATIVE, LARGE GLOBAL PHARMACEUTICAL COMPANY AND GROW PROFESSIONALLY.

If you love writing, have a passion for CMC, have past experience with vaccines or a desire to learn more about these vital products, and are looking for an opportunity that will allow you to continue to have the flexibility of working from home while gaining tremendous professional experience and working with some of the Industry’s BEST, then Parexel's Regulatory Consulting team has an amazing opportunity for you!

As a Senior Regulatory Affairs Associate/Consultant, CMC you will: 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 copy-editing check Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data QualificationsBA/BS in scientific or technical discipline or advanced degree 3-5 years of biopharmaceutical regulatory CMC experience (depth of experience will determine Senior Associate or Consultant level role) 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) Past CMC vaccines experience is preferred, however, candidates with strong CMC small molecule, biologics, and/or large molecule experience will also be considered This role may require <30% domestic and/or international travel in the future

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.