Director, Regulatory Affairs - Clinical

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Job description

Overview:
Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan's most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), and amyotrophic lateral sclerosis (ALS).

MTPA is rapidly expanding its operations across all functional areas. MTPA's commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare diseases treatments including RADICAVA (edaravone) injectables in 2017, EXSERVAN (riluzole) oral film in 2021, and RADICAVA (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.

The Director, 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/or 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.

Responsibilities:
Actively leads development and implementation of regulatory strategies for assigned programs and ensures cross-functional alignment.

Leads regulatory activities within the project teams (nonclinical, clinical) to assure timelines and milestones.

With support of Commercial RA, develops initial product labeling and assesses proposed product claim proposal (pre-NDA), if needed.

Interfaces with Business Development and other partners as required during due diligence activities to assess commercial viability of potential drugs.

Provides Regulatory Implementation Risk Assessment and mitigation strategy 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.

Leads as a key member of Global Regulatory Project Teams.

Leads multidisciplinary team responding to Health Authority questions during the Pre-IND, IND and BLA/NDA review phases for assigned projects.

Prepare regulatory agency responses and other documents intended for submission to global health authorities, including information requests, meeting requests, and briefing documents.

Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (e.g., contract research organization teams and vendors).

Supports Quality Assurance activities during pre-approval GCP and GMP FDA/EMEA/PMDA inspections.

Expands and precedes the organization's 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.

As required, serves as a global regulatory lead on a specific or assigned clinical program.

Qualifications:
Minimum of 8-10 years of regulatory affairs experience. Experience in biotechnology and pharmaceutical industry is acceptable.

Experience with rare disease drug development including oncology, neurology, immunology/ inflammation, and metabolic diseases is a plus.

Experience with designing and executing creative development strategies for New Chemical Entity (NCE) or biologics development programs.

Experience preparing and overseeing regulatory submissions, including Pre-IND, INDs/Clinical Trial Applications and Marketing Applications in electronic Common Technical Document (eCTD) format.

Experience interacting with FDA representatives and organizing FDA meetings including Pre-IND, FDA Pilot programs, End of Phase 1/2 meetings. Orphan drug designation, Pediatric Study Plan and pre-NDA.

Meaningful experience in submission of IND/CTA and BLA/NDA is a plus

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 up to 10% as needed within a global work environment.

Our Value Proposition:

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.

MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

The salary range for this position is $155,000 - $264,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.

This position is eligible to participate in our Long-Term Incentive (LTI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.

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