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 Senior Director, Commercial Regulatory Affairs, is responsible for the development and execution of the post-approval regulatory strategy, post-marketing commitments,post-marketing development and maintenance,regulatory operations and filings-related activities including regulatory submissions, regulatory compliance, regulatory advice and counseling, advertising and promotion reviews, and marketing application registration updates in close collaboration with Mitsubishi Tanabe Pharma Corporation, Inc. (MTPC) and all subsidiaries.Regulatory activities pertain primarily to marketed products in US and Canada.

In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC-RA, will review and assess all commercial communications includingadvertising and promotional information, materials, and activities to ensure consistency with product labeling and with all applicable regulations. TheSenior Director, Commercial Regulatory Affairs will stay abreast of changes in the global/U.S./Canadian regulatory framework, analyze proposed legislation/guidance that could impact the business and its products, and in conjunction with the Regulatory Affairs, Regulatory Strategists, recommend appropriate actions to senior leadership.

Responsibilities

• Actively leads, develops, and implements strategic and tactical support for commercial, post approval regulatory activities for successful and compliant promotion and scientific engagement activities and review submission packages, labeling revisions, and promotional materials for regulatory compliance including supporting launch and market growth for approved products.

• Develops FDA/OPDP and Health Canada strategy and execution of related communications as part of thePromotional Materials Review Committee (PMRC), a cross-functional team of representatives from various business areas (Marketing, Market Access, Sales Training, Communications/Public Relations, Legal, Medical Affairs, and Regulatory Affairs).

• Serves as a member of the Promotion Marketing Review Committee (PMRC) to apply accurate and up-to-date marketed product labeling and approval of promotional and non-promotional materials.

• Collaborates closely with the PMRC Manager and other members to quickly resolve issues that arise (escalating to higher levels if needed), in order to efficiently move documents towards final regulatory submission. Provides overall management, quality control (QC) and tracking for submission processes.

• Collaborates with Commercial, Medical Affairs, Quality, Legal, and Development teams to ensure successful and compliant promotion and scientific engagement activities and review submission packages, labeling revisions, and promotional materials for regulatory compliance. In addition,collaborateswith Medical Affairs regarding acceptable practice for solicited and non-solicited inquiries and also works with Quality Assurance and Legal to develop and implement SOPs, as appropriate, and to monitor product-related activities for regulatory compliance.

• Oversees the Implementation of labeling control coordination version control of package inserts, QC check of package inserts and packaging labels; and oversees staff members who serve as Secretary of the Labeling Committee.

• Conducts regulatory compliance reviews of strategies, information, activities & materials including but not limited to: promotion, websites, new product/indication launches, medical conventions, healthcare economic information, publications, sales training, internal and external communications, grants, advisory boards, scientific exchange, etc.Stays abreast of new regulatory guidance that might relate to Advertising & Promotions, particularly any new regulations and guidance coming from OPDP and PAAB. Advises and updates supervisor and related teams, as appropriate, to ameliorate potential negative business impacts. Maintains an awareness of legislation, assesses its impact on the regulatory status of currently marketed products, and makes recommendations to senior management to mitigate or avert risks.

• Ensures regulatory commitments (e.g., DHCP letters, labeling changes, risk management plans, etc.) are carried out as required within established timelines and in compliance with applicable regulations by driving regulatory reporting activities including but not limited to: Annual Reports, post-approval manufacturing changes, and stability updates in coordination with MTPC, MTPA and MTDA QA, PV and RA and with manufacturing operations Assists preparation of NDA Annual Reports, safety updates, and Phase 4 FDA commitments.

• Manages interactions with US FDA, OPDP and Health Canada for regulatory related activities by drafting pre-meeting briefing materials, preparing for sponsor interactions at regulatory meetings, and ensuring appropriate follow-up. Drafts responses to Notice of Violations (NOVs), Warning Letters, etc.

• Serves as primary contact to the regulatory authorities as needed.

• Identifies and monitors legislative, regulatory and policy issues. Develops risk assessment plans.

• Works with development and commercial partners as required; assists in due diligence activities.

• Collaborates with, communicates with, and as required, oversees the work of external service providers or suppliers directly involved in the drug development process.

• Develops and maintains current commercial regulatory knowledge and provides guidance to commercial regulatory staff and company management; identifies the need for new or expanded commercial regulatory policies, processes, and SOPs, and approves and ensures implementation to establish a compliant culture.

• Provides leadership and guidance by promoting teamwork, discerning hiring needs, as well as coaching, mentoring, training, and developing commercial regulatory staff and other team members.

Qualifications

• Bachelor's degree or equivalent work experience in a technical discipline (e.g., Pharmacy, Chemistry, Microbiology, etc.).

• Master’s Degree or PhD is preferable.

• Minimum of 15- years of experience in Regulatory Affairs with a proprietary US based pharmaceutical manufacturer overseeing regulatory submissions, regulatory marketing compliance and advertising programs, materials, tactics, and activities – OR – 12 years of experience with Advanced Degree.

• Experience interacting with US FDA CDER especially related to NDA annual reports, promotions / advertisement campaigns and regulatory policies. Similar experience with Health Canada is preferred, though not required.

• Experience overseeing the work of external service providers and suppliers in the drug development process.

• Experience with rare diseases and orphan drugs is preferred.

• Meaningful hands-on experience with managing a Regulatory team.

• Expert understanding of post-market drug product related Regulatory Affairs activities.

• Outstanding knowledge of FDAregulatory framework, particularly OPDP regulations and guidance,regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends, and proven ability to interpret and apply creative and compliant approaches for achieving desired outcomes. Knowledge of Health Canada regulations is a plus.

• Expert understanding of global regulations and regulatory agencies.

• Demonstrated track record of proactively reacting to changes in the regulatory landscape and mitigating any impact on ongoing or planned advertising/promotional campaigns through collaborative interactions with internal and external stakeholders.

• Demonstrated track record of direct interaction with the FDA and/or OPDP.

• Outstanding leadership skills: ability to make risk based quality and regulatory decisions, manage the global requirements, and develop highly effective teams that work effectively together.

• Strong negotiation and interpersonal skills with a good awareness of global cultural differences – promotes coordination between QA and RA functions both between US entities and MTPC Japan.

• Demonstrated ability to contribute successfully in a multi-disciplinary team environment / matrix organization

• Outstanding organizational/project management strengths with ability to multitask while consistently meeting deadlines.

• Excellent oral and written communications skills.

• Outstanding detail orientation coupled with strong quality control and proofreading skills.

• Proven competency in MS Office, including Excel.

• Competency with Adobe products and/or previous experience using Veeva Vault PromoMats is a plus.

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.

Job Locations US-NJ-Jersey City

Job ID 2024-1777

# of Openings 1

Category Regulatory Affairs

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.