Director, Regulatory Affairs-Late Stage (Remote)

$180,000 - $240,000/Yr

Mitsubishi Tanabe Pharma - Jersey City, NJ

Full-time - Senior

Remote - Jersey City, NJ

Chemical Manufacturing

About the position

Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which has a storied reputation of more than 300 years. MTPA is rapidly expanding its operations across all functional areas, with a commitment to patients and their communities through a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases. The Director, Regulatory Affairs provides strategic global regulatory guidance to cross-functional project teams responsible for product development, defining and implementing regulatory strategies, and supporting 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.
• Develops initial product labeling and assesses proposed product claim proposal (pre-NDA), if needed.
• Interfaces with Business Development and other partners 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 stakeholders.
• Coordinates all aspects of regulatory submissions relevant to assigned programs, including regulatory workflow, reviewing technical documents, and tracking submission timelines.
• 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.
• Prepares regulatory agency responses and other documents intended for submission to global health authorities.
• Acts as liaison between Regulatory Affairs and other functional areas, including external contractors.
• 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.
• Maintains knowledge and monitors changes in pertinent laws, regulations, and guidance.
• 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.
• Serves as a global regulatory lead on a specific or assigned clinical program as required.

Requirements

• Minimum of 8-10 years of regulatory affairs experience.
• Experience in biotechnology and pharmaceutical industry.
• Experience with rare disease drug development including oncology, neurology, immunology/inflammation, and metabolic diseases.
• Experience with designing and executing development strategies for New Chemical Entity (NCE) or biologics development programs.
• Experience preparing and overseeing regulatory submissions in eCTD format.
• Experience interacting with FDA representatives and organizing FDA meetings.
• Comprehensive understanding of FDA regulations and ICH guidance.
• Detail-oriented with the ability to detect and correct errors in documents.
• Excellent communication (written and verbal) and collaboration skills.
• Expertise in translating regulatory requirements into practical plans.
• Proven track records working with regulatory agencies.

Nice-to-haves

• Meaningful experience in submission of IND/CTA and BLA/NDA.

Benefits

• Medical and Dental health benefits.
• Short-term and long-term disability plans.
• Company Paid and Supplemental Life insurance.
• Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection.
• Generous PTO policy based on tenure, commencing with 24 PTO days.