Regulatory Affairs Consultant (CMC Writer), client dedicated

Parexel is currently looking for an experienced Regulatory Consultant, CMC Technical Writer to join our client-dedicated team to support our reputable pharmaceutical client.

Key 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

Desired Abilities: Ability to work with a high level of integrity, accuracy, and attention to detail Problem-solving skills to evaluate technical information and appropriately transfer to regulatory applications Strong organizational skills in order to maintain a high level of productivity, innovation, to ensure assignments are completed on-time with a high level of quality Ability to work independently with minimal supervision as well as part of a team environment Proven ability to manage multiple projects, identify and resolve regulatory issues Excellent oral and written communication skills QualificationsBA/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 the 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