Director, Regulatory Affairs
Posted on Apr 6, 2021 by MT Pharma
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
The Director of Regulatory Affairs provides strategic global regulatory guidance to cross-functional project teams responsible for product development. The successful candidate has a proven track record in the development of drugs, biologics/vaccines, and also in the rare disease space. In this role, the Director defines and implements regulatory strategies; works with cross-functional project teams to execute the agreed-upon strategies; supports departmental activities with regards to clinical trial conduct and regulatory submissions.
Actively leads development and implementation of regulatory strategies for assigned programs and ensures cross-functional alignment.
Leads regulatory activities (nonclinical, clinical and CMC) to assure timelines and milestones.
Interfaces with Commercial Regulatory Affairs developing GRASP's.
With support of Commercial RA, develops initial product labeling and assesses proposed product claim proposal (pre-NDA).
Interfaces with Business Development and other partners as required during due diligence activities to assess commercial viability of potential drugs.
Provides Regulatory Risk Assessment (RRA) during various phases of product development.
Monitors current and proposed regulatory and legal issues and ensures that key initiatives are communicated to the stakeholders.
Coordinates all aspects of regulatory submissions relevant to assigned programs, including coordinating regulatory workflow, reviewing technical documents (nonclinical, clinical, and CMC), developing and tracking submission timelines, and supervising preparation of regulatory submissions to ensure compliance with regulations and guidelines. It is expected that the Director will also have some experience outside the US.
Reviews and approves protocols, reports, and documents used in regulatory submissions.
Prepares IMPD to support international CTA submissions.
Leads as a key member of Global Regulatory Project Teams.
Leads multidisciplinary team responding to Health Authority questions during the IND and NDA review phases for assigned projects.
Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg, contract research organization teams and vendors).
Supports Quality Assurance activities during pre-approval GCP and GMP FDA/EMEA/PMDA inspections.
Expands and precedes the organizations policies and procedures for regulatory affairs and compliance to establish a compliant culture.
Maintains knowledge and monitors changes in pertinent laws, regulations, and guidance. Interprets external developments and informs/educates internal stakeholders.
Identifies the need for new regulatory policies, processes, and SOPs, and approves and ensures implementation.
Works closely with Regulatory Operations to ensure e-CTD compliance.
Bachelor's Degree is required, preferably in a scientific discipline.
Higher level degree (eg, Master's, PhD or PharmD) is preferred.
Regulatory Affairs Certification (RAC) is preferred.
Minimum of 8-10 years of regulatory affairs experience. Experience in biotechnology or pharmaceutical industry is acceptable.
Experience with designing and executing creative development strategies for NCE or biologics development programs.
Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in electronic Common Technical Document format.
Experience with international clinical trials and regulatory documentation.
Comprehensive understanding of FDA regulations and ICH guidance, as well as comprehensive experience in the drug development process.
Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
Excellent communication (written and verbal) and collaboration skills.
Expertise in translating regulatory requirements into practical, workable plans.
Experience in preparation of critical submission documentation, and communications with FDA and other regulatory agencies.
Ability to build effective relationships within a team/collaborative environment, with a high level of professionalism.
Proven track records working with regulatory agencies.
Required to travel as needed within a global work environment
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