Regulatory Project Manager CMC Technical writing (various levels)

Fantastic opportunity for an experienced CMC Technical Regulatory Writer to join Parexel's highly-respected Regulatory Consulting Team as a Regulatory Project Manager - CMC Technical Writing!

In this role you will work closely with an amazing team on a large, dedicated enterprise client partnership and provide regulatory strategy and oversight to a large portfolio for this client. You will ensure regulatory strategies are incorporated into regulatory submission documents and such documents are written and managed to team/project expectations and conform to the regulatory and company standards. This position reports to the Director of CMC Regulatory Affairs Writing and is responsible for the following:

•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 QualificationsTo ensure success, you will have:

• 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

• Willingness to work collaboratively by incorporating diverse perspectives

• Proactively seeks out and recommends process improvements

• Proven ability to manage multiple projects, identify and resolve regulatory issues

• Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company

EDUCATION AND EXPERIENCE

• BA/BS in scientific or technical discipline or advanced degree

• At least 3-5 years of biopharmaceutical regulatory experience for a Consultant level role, 7+ years for a Senior Consultant, and 12-15+ for a Principal Consultant

• 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). CMC vaccine or biologics experience is highly preferred, however, consideration will be given to strong CMC small-molecule candidates too

• 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

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.