Regulatory Affairs Consultant - CMC Large Molecule

Excellent opportunity for an experienced Regulatory Affairs CMC professional with large molecule and project management experience to bring your talent, excellent communication skills, strong writing experience, and CMC expertise to Parexel Consulting as a Regulatory Affairs Consultant!

In this highly visible Regulatory Affairs Consultant role, you will partner closely with a large multinational pharmaceutical company and work closely with the Client’s Director of CMC Regulatory Affairs Writing to:

• Develop and manage a Project Plan to enable successful delivery of the CMC components of a Marketing Application and/or late-stage regulatory submission.

• Prepare and coordinate Project Plan for the CMC-sections (Module 2.3 and 3) and subsequent plan through the review and approval of submission-ready documents

• Monitor and manage progress to the Plan, working directly with the authors and reviewers/approvers to facilitate progression. Identify risks to the Plan, develop mitigation strategies and run risk reviews to minimize project delays

• Maintain a project dashboard for tracking and reporting progress against the Plan to the wider team and stakeholders.

• Attend project meetings as requested and schedule and lead additional meetings and/or Joint Planning Sessions which are necessary to develop and manage the Plan.

• Collaborate with RA CMC lead to provide regulatory support for assigned projects

• Understands CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA)

• Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex plans Qualifications• At least 5+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity with at least 3+ years of CMC regulatory writing experience for large molecule products

• A strong understanding of all aspects of developing a pharmaceutical product and the manufacturing requirements

• Ability to work with a high level of integrity, accuracy, and attention to detail

• Be a performance-driven individual, with a strong sense of urgency, exceptional organizational credibility, and deep understanding of the business.

• Demonstrated knowledge of all relevant components of project management, including management of scope, time, cost, quality, integration, influence & negotiation, communications, risk, and scenario planning across all project management focus areas, namely initiating, planning, executing, monitoring, controlling, and closing of projects (i.e. strong theoretical knowledge).

• 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

Travel Requirements – up to 20% Domestic or International travel may be required 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.