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

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-ready efforts; and provides regulatory oversight during follow-up to inspections and audits to minimize potential for findings of non-compliance.

• Represents as required the regulatory function in the evaluation of new product opportunities internally and externally.

• Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies, recommends, and as appropriate, drafts new or expanded regulatory policies, processes, and SOPs. Upon approval, ensures implementation of same to establish a compliant culture.

• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.

Qualifications:

• Bachelors or Masters degree in a scientific discipline.   PhD or PharmD or equivalent experience strongly preferred.

• Regulatory Affairs Certification highly preferred.

• Minimum of 6 years of CMC regulatory experience within the pharmaceutical or biotechnology industry.

• Knowledge of the regulatory framework for Combination Products/Medical Devices in major markets is essential.

• Significant experience with registration of Combination Products/Medical Devices.

• Proven track record of contributing to design and execution of creative development strategies and programs for drugs and/or biologics/vaccines.

• Comprehensive experience in the drug development process in the US.

• Comprehensive experience in the drug development process internationally (particularly in Japan, Europe, and Canada) is preferred.

• Experience in the post marketing area and with related requirements.

• Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in eCTD format.

Skills:

• Solid understanding and applied knowledge of regulatory requirements (FDA, ICH) for the development and approval of investigational products.

• Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.

• Excellent communication (written and verbal) skills; proven ability to deliver effective presentations concerning complex topics.

• Proven ability to collaborate across multiple functions and build effective relationships within a team/collaborative environment, with a high level of professionalism.

• The ability to travel up to 10% domestically, but with occasional project-related international travel.

Canidates based on the east coast are highly preferred.

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EEO Disclaimer

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