$190K — $200K *
The Director, CMC Regulatory Affairs provides strategic regulatory guidance to cross-functional project teams responsible for product development and post marketing commitments. He/she recommends global CMC regulatory strategies, and upon approval by management, implements those strategies, translating regulatory requirements into practical, workable plans in order to facilitate timely drug development and registration. The Director, CMC Regulatory Affairs 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.
§ Recommends CMC regulatory strategy plans and guides those recommendations through the internal approval process.
§ Implements strategy plans and activities 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.
§ Acts as RA CMC regulatory expert for global project teams/task forces and is accountable for recommending global CMC regulatory strategy.
§ Ensures PM NDA compliance for post approval changes and US/Canada submission.
§ Ensures 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.
▬ oversees 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.
▬ participates during project review..
§ Serves as primary CMC regulatory contact for assigned projects with the FDA and other regulatory agencies:
▬ establishes and maintains contacts and effectively partners with FDA, DEA and other federal agencies to direct, co-ordinate and implement preparation of all CMC regulatory submissions and provide regulatory support across all areas.
▬ plans, executes, and leads successful regulatory agency CMC meetings and interactions per regulatory strategy.
§ Guides CMC team in Japan, Europe, and US/Canada towards globalization and coaches them under US regulatory framework.
§ Identifies and monitors legislative, regulatory and policy issues related to quality. Develops risk assessment plans and presents for review/approval. Develops and presents information to educate internal stakeholders about risk (e.g., corporate evaluations on regulatory risk-benefit, options for risk mitigation).
§ Develops and implements 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 the regulatory function as required 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.
§ Oversees the work of one or more CMC regulatory consultants.
§ Reports directly to the Executive Director, Regulatory Affairs & CMC
§ Oversees the work of consultant(s). Role may expand over time to include supervision of FTEs.
§ Works cross-functionally and collaboratively with internal departments, global counterparts, and liaisons with external partners (CMOs, consultants, vendors)
§ Bachelors or master’s degree in a scientific discipline or equivalent.
§ Strongly preferred: PhD or PharmD or equivalent experience; Regulatory Affairs Certification.
§ Minimum of 8 years of CMC regulatory experience within the pharmaceutical or biotechnology industry.
§ Experience managing direct reports or contractors is preferred.
§ Proven track record designing and executing creative development strategies and programs for drugs, biologics/vaccines and also in the rare disease space.
§ Comprehensive experience in the drug development process in the US and internationally (particularly in Europe and Japan).
§ Experience in the post marketing area and related requirements.
§ Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in eCTD format.
§ Solid understanding and applied knowledge of regulatory requirements (FDA, ICH) for the development and approval of investigational products.
§ Excellent communication (written and verbal) skills; proven ability to deliver effective presentations concerning complex topics.
§ Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
§ Proven ability to collaborate across multiple functions and build effective relationships within a team/collaborative environment, with a high level of professionalism.
§ Willingness to travel up to 15% domestically and internationally.
Valid through: 6/8/2021
$130K — $140K + $15K bonus *