Regulatory Affairs Consultant

OVERVIEW

Provides leadership for all regulatory aspects of Chemistry, Manufacturing and Controls (CMC) and assures optimal functioning of internal and external interfaces between Regulatory CMC and stakeholders for activities across all product development projects. Closely interacts with multiple functions to create high-quality regulatory submissions that support product development strategy.

ROLES AND RESPONSIBILITIES

In this position, the Regulatory Affairs Consultant will support clients in a variety of ways:

• Proactively manages regulatory CMC aspects of client programs, including overseeing the preparation and submission of CMC submissions supporting clinical trial applications and marketing applications appropriate to the development phase.
• Ensures timely delivery of high-quality CMC documents, including regulatory authority requests for information, meeting briefing books, meeting minutes, IND/IMPD/CTA submissions, NDA /MAA submissions, and DMFs while assuring all documents meet regulatory requirements and quality compliance.
• Facilitates the development of, reviews, and comments on all technically complex CMC documentation for submission to regulatory authorities, including process development, process validation, analytical method development, and analytical method validation supporting the establishment of specifications and in-process, release and stability data and information appropriate to the phase of development.
• Articulates complex Regulatory CMC issues to internal project teams and external stakeholders to support global development and commercialization of drug candidates.
• Evaluates proposed manufacturing and quality changes for impact on ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
• Manages interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, rapid review, and approval of clinical trial applications, marketing applications, amendments/supplements/variations, and other submissions which present CMC information.
• Develops and maintains excellent relationships with regulatory authorities, internal functional groups, contract manufacturing organizations, and corporate partners.
• Support Quality Assurance in preparing and hosting regulatory inspections.
• Maintains current understanding of the regulations and guidelines about CMC/Quality information relevant to client’s development programs
• Supports Management Team in the development of overall product development and registration strategy.
• Collaborates with Management Team to identify resource needs, including consultants and new associates advising on skill sets to meet needs.

QUALIFICATIONS

Candidates must have at least 15 years of experience in a Regulatory CMC capacity with direct experience in authoring and strategic decision-making. B.S. or higher in the sciences

Preferred Skills:

• BS in a scientific discipline, a combination of relevant education, and applicable job experience may be considered.
• 15+ years in Regulatory Affairs CMC plus recognized technical expert.
• Demonstrated ability to deliver high-quality regulatory documents. Thorough understanding of the drug development process, pharmaceutical industry, and healthcare environment, including regulatory requirements, guidelines, and market and policy trends.
• Extensive regulatory experience across the value chain including IND/CTA/IMPD, NDA/BLA/MAA, lifecycle management, interactions with Regulatory Authorities, and developing and implementing complex CMC regulatory strategies with a proven track record of significant regulatory accomplishments.
• Prior success in filing IND/CTA/IMPD and NDA/BLA/MAA within timelines requires global submission experience.
• Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders, including external partners and regulatory authorities.
• Highly resourceful team player, with the ability to be extremely effective independently
• Strong negotiating skills: thinking creatively, developing creative solutions, and effectively communicating solutions to stakeholders.
• PC literacy is required; Proficient use of technology, including MSOffice skills (Outlook, Word, Excel, PowerPoint, document management systems, and Internet resources is expected).
• Ability to travel up to 20% as required.
• Knowledge of a variety of dosage forms is a plus.