Design Space InPharmatics (DSI), a nation-wide Consulting group, is seeking a Senior Consultant, CMC Regulatory Affairs, responsible for providing 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 independently author high quality regulatory submissions that support product development strategy. The Candidate will work remotely in a team environment.
Role 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 authoring, preparation and submission of marketing applications supporting clinical trial applications and marketing applications appropriate to phase of development.
- 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 establishment of specifications and in-process, release and stability data and information appropriate to 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 to ongoing and existing filings and provides 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 pertaining to CMC/Quality information relevant to DSIs clients development programs.
- Supports DSI Management Team in the development of overall product development and registration strategy.
- Collaborates with DSI Management Team to identify resource needs, including consultants and new associates advising on skills sets to meet needs.
Qualifications and Education Requirements
- B.S. in a scientific discipline or an equivalent combination of education, training, and experience. Candidates must have a minimum of 15 years of experience in a Regulatory CMC capacity with direct experience in authoring and strategic decision making.
- Demonstrated ability to author and deliver high quality regulatory documents. Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements, guidelines, and market and policy trends.
- Extensive regulatory experience across value chain including IND/CTA/IMPD, NDA/BLA/MAA, lifecycle management, interactions with Regulatory Authorities, developing and implementing complex CMC regulatory strategies with a proven track record of significant regulatory accomplishments.
- Prior success authoring and filing IND/CTA/IMPD and NDA/BLA/MAA within timelines is required; global submission experience required.
- 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: able to think creatively, develop creative solutions and effectively communicate solutions to stakeholders.
- PC literacy required; Proficient use of technology including MS Office skills (Outlook, Word, Excel, PowerPoint, document management systems, and Internet resources is expected).
- Ability to travel up to 20% as required.
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. DSI reserves the right to change this description at any time and require the consultant to perform other tasks as required due to business needs. This is a great opportunity for someone who is looking to join a growing company that is the already the acknowledged market leader in the dynamic and expanding regulatory drug development services arena focusing on CMC.
- Knowledge of a variety of dosages forms is a plus.
Candidate must have USA permanent work authorization. No sponsorship for work visas is available.
How To Apply:
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