Senior Consultant, Regulatory CMC - Combination Products/Medical Devices (Remote)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Senior Consultant, Regulatory CMC - Combination Products/Medical Devices provides strategic regulatory guidance to cross-functional project teams responsible for product development and post marketing commitments. The Senior Consultant, Regulatory CMC - Combination Products/Medical Devices, with the support from the Executive Director, Regulatory Affairs (RA), recommends global CMC regulatory strategies, and upon approval by management, implements those strategies, translating regulatory requirements into practical, workable plans to facilitate timely drug development and registration. The Senior Consultant, Regulatory CMC - Combination Products/Medical Devices works with cross-functional project teams to execute the agreed-upon strategies; interacts with regulatory agencies to negotiate agreements; coordinates the planning and conduct of regulatory agency meetings on CMC; and supports departmental activities with regards to clinical trial conduct and CMC regulatory submissions.

Key Responsibilities:

• Actively leads development and implementation of CMC regulatory strategy plans for combination products/medical devices that are in alignment with project timelines and guides those recommendations through the internal approval process.

• Implements strategy plans and activities, with the support from the Executive Director RA, for assigned programs and coordinates as needed with CMC members in Japan, Europe, and US/Canada and with RA project management for assigned developmental and commercial or post approval projects.

• Leads RA CMC regulatory activities for global project teams/task forces and provides recommendations on global CMC regulatory strategy.

• Ensures PM NDA compliance for post approval changes and US/Canada submission.

• Preparing CMC documentation to support global regulatory filings, including liaising with regional representatives and relevant SMEs to draft technical content for CMC submissions from development through commercial to support life-cycle management.

• Convey regulatory expectations for the device aspects in a manner that is easily understood by both technical and non-technical teams.

• Act as an advisor and partner with functional units on the implementation of Drug-Device Combination and Medical Device regulatory requirements.

• Contributes to the overall program execution of high quality, effective IND, NDA and MAA and related CMC regulatory submissions and responses to regulatory agency requests:

  • reviews CMC submissions in support of clinical trials and marketing applications, and their amendments.

  • actively participates in product development project teams advising on submission preparation timelines, processes, and requirements.

  • works closely with Regulatory Publishing to ensure electronic Common Technical Document (eCTD) compliance.

  • contributes to development and strategy of CMC regulatory submissions to ensure compliance with all FDA regulations and guidelines.

  • provides CMC expertise and Regulatory Review for CMC submissions for US/Canada.

• Supports CMC team in Japan, Europe, and US/Canada towards globalization and advises them under US regulatory framework.

• Identifies and monitors legislative, regulatory and policy issues related to quality.

• Contributes to risk assessment plans and may present for review/approval.

• Contributes to development and presentation of information to educate internal stakeholders about risk (e.g., corporate evaluations on regulatory risk-benefit, options for risk mitigation).

• Contributes to development and implementation of registration strategy plans (RSP) and ensures cross-functional alignment with overall development plan.

• Acts as liaison between CMC Regulatory Affairs and other functional areas, as required, including external contractors (e.g., CMO, consultants and vendors); participates as a key member of Global CMC Regulatory Teams; and represents CMC Regulatory Affairs on various other process and procedural cross-functional teams.

• Provides CMC regulatory support for Quality Assurance and quality inspection-re