Job Number: 8578
The Regulatory Affairs Director position supports the drug development and registration efforts for specialty drug products, peptides and proteins across different therapeutic areas. The candidate will manage and support the regulatory activities necessary to develop Marketing Applications for product registration. The position will be responsible for coordinating, preparing and maintaining PAS, NDAs, BLAs and interfacing and managing CMO s involved in dossier preparation.
Provides program leadership and develops and refines regulatory strategy for specialty drug products, including peptide and protein-based programs in various stages of development. Possesses a strong, scientific knowledge base in Analytical Chemistry, API and Drug Product Manufacturing.
Represents Regulatory Affairs on cross-functional internal teams (CMC, Product Development, Clinical, and Quality Assurance) and with Contract Research and Manufacturing Organizations to ensure that information is identified, obtained and effectively captured to support the registration of products.
Compile, review and approve all aspects of high quality regulatory filings for specialty drug programs. Thorough understanding of all aspects of FDA, NDA, ANDA and BLA review divisions. Demonstrates leadership and comprehensive understanding of peptide and protein-based regulatory guidelines by applying interpersonal skills and expert regulatory knowledge to identify, communicate, address, and overcome challenges that arise during development and commercialization.
Conduct routine regulatory surveillance and be knowledgeable of key global guidance documents, regulations, or directives and effectively communicate any impact of these initiatives on regulatory strategy.
- Leads planning, execution, and management of regulatory submissions for applications, and post-approval life cycle activities, as needed.
- Member of technical development teams which require experienced interpretation of applicable FDA & ICH regulations to ensure regulatory compliance.
- Leads regulatory compliance assessments with respect to filing requirements for assigned peptide and protein-based drugs throughout development and the commercial life cycle.
- Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements.
- Represents company at FDA meetings and interacts directly with FDA, as required.
- Coordinate the completion of regulatory specific documents such as FDA Meeting Requests, Briefing Documents, Fast Track and Priority Review Designations, Specialty Protocol Assessments, Orphan Drug Petitions, etc., as required.
- Ensures project team colleagues and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner.
- Stays abreast of current and evolving regulatory requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development.
- May be required to identify and interact with regulatory consultants (as needed)
- Other duties as needed
BS/BA Degree in a scientific/engineering discipline required, Advanced Degree preferred. Regulatory Affairs Certificate (RAC) also preferred.
10 + years regulatory experience (some biologics experience required). Alternatively, 5+ years regulatory experience combined with 5+ years relevant technical drug and/or biologics experience (e.G. Pharmaceutical Development, Process Development, Analytical Development, Production, Quality Assurance).
Proven ability to liaise with Regulatory Officials in Agency Interactions. Demonstrated track record for successful interactions with FDA (CDER), and possibly other global health authorities, related to regulatory submissions.
Understanding of scientific principles and regulatory requirements relevant to biologics development, registration, and post-market support. Proven ability to provide strategic regulatory guidance to teams. Experience with managing NDA/BLA content and format for protein/peptide products required.
Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
Knowledge of eCTD content/format requirements is required.
Ability to work independently in a fast-paced, deadline driven environment is required.
Demonstrated leadership, problem-solving ability, flexibility and teamwork.
Excellent written and oral communication skills are required.
Strong organizational skills, including the ability to prioritize workload, is required.
Experience with process development, analytical characterization, process scale-up and/or regulatory registration of protein/peptide drug substances or drug products (including sterile parenteral dosage forms) is required.
Experience with NDA is required and with ANDA filings is beneficial.
Familiarity with global regulations, including EU, is beneficial.
Exercises good judgment in elevating and communicating actual or potential regulatory risks to project teams and line management.
Experience in Endocrinology with peptide or protein products is preferred.