Job Abstract

Job ID

2024-1857

# of Openings

1

Category

Regulatory Affairs

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), amyotrophic lateral sclerosis (ALS), and Parkinson's (PD).

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 Senior Director, Regulatory Affairs - Clinical (Early Development), may be called upon to guide a team of Clinical Regulatory Affairs professionals providing strategic regulatory guidance to cross-functional project teams and responsible for product development and post marketing commitments. He/she defines and implements global regulatory strategies, translating regulatory requirements into practical, workable plans to facilitate timely drug development and registration. The Senior Director, Regulatory Affairs - Clinical also works directly with cross-functional project teams to execute the agreed-upon strategies, interacts with regulatory agencies to negotiate agreements, coordinates the planning and conduct of regulatory agency meetings, and oversees departmental activities with regards to clinical trial conduct and regulatory submissions.

• Actively leads development and implementation of regulatory strategy plans and activities for assigned programs, typically overseeing one or more therapeutic areas, and coordinates strategy with RA project management for assigned regulatory projects.
• Develops and implements registration strategy plans (RSP) and ensures cross-functional alignment with overall development plan.
• Is assigned as lead contact with FDA and Health Canada or delegated to direct reports as needed.
• Interacts with the Commercial RA counterpart to ensure input into the development plans to support marketing product claims.
• Acts as liaison between Regulatory Affairs & CMC and other functional areas, including external contractors (e.g., CRO teams and vendors); participates as a key member of Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and procedural cross-functional teams.
• Ensures the overall program execution of high quality, effective IND, CTA, NDA, NDS and MAA and related regulatory submissions and responses to regulatory agency requests:
  
  • develops and tracks submission timelines with RA Project Operations
  • actively participates in product development project teams advising on submission preparation timelines, processes, and requirements.
  • prepares paper and electronic submissions in cooperation with Regulatory Publishing to support development project plans and timelines.
  • works closely with Regulatory Publishing to ensure electronic Common Technical Document (eCTD) compliance.
  • reviews and leads preparation of IMPD to support international CTA submissions.
  • oversees preparation of regulatory submissions to ensure compliance with all FDA regulations and guidelines.
• Ensures the effectiveness of execution and output for Global Regulatory Project Teams.
• Actively participants in preparation in all submissions to FDA and other regulatory agencies. Carefully reviews and provides analysis of the content of regulatory agencies responses and prepares plans for implementation.
• Identifies and monitors legislative, regulatory and policy issues. Develops risk assessment plans. Develops and presents information to educate internal stakeholders about risk (e.g., corporate evaluations on regulatory risk-benefit, options for risk mitigation).
• Develops and implements registration plans and ensures cross-functional alignment with overall development plans.
• Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (e.g., CRO teams and vendors); participates as a key member of Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and
• procedural cross-functional teams.
• Assigns reports to represent early- and late-stage project teams and ensures timely and sound regulatory strategy is provided.
• Works with development partners as required; assists in due diligence activities.
• Provides regulatory support for MTPA Quality Assurance and Pharmacovigilance inspection ready efforts; and provides regulatory oversight during follow-up to inspections and audits to minimize potential for findings of non-compliance.
• Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish
• a compliant culture.
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.
• Provides leadership and guidance by promoting teamwork, discerning hiring needs, as well as coaching, mentoring, training and developing regulatory staff and other team members.

• Bachelor’s or Master’s degree in a scientific discipline or equivalent.
• Strongly preferred: PhD or PharmD or equivalent experience; Regulatory Affairs Certification.
• Minimum of 15 years of regulatory experience within the pharmaceutical or biotechnology industry with demonstrated success in RA strategy and submission.
• Minimum of 5 years of experience managing direct reports or leading team members.
• Proven track record designing and executing creative development strategies and programs for drugs, biologics/vaccines and in the rare disease space.
• Comprehensive experience in the drug development process in the US and internationally (particularly in Europe and Japan).
• Significant hands-on experience in early-stage development programs is highly preferred.
• Experience in the post marketing area and related areas are a plus.
• Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in eCTD format.
• Preferred: Experience with international clinical trials and associated regulatory documentation.
• Expert understanding and applied knowledge of regulatory requirements (FDA, ICH) for the development and approval of investigational products.
• Excellent communication (written and verbal) skills; proven ability to deliver effective presentations concerning complex topics to wide-ranging audiences.
• Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
• Proven ability to collaborate across multiple functions and build effective relationships within a team/collaborative environment, with a high level of professionalism.
• Required to travel up to 10% domestically and internationally.

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 $194,000 - $329,000. 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.