Associate Director, Regulatory Affairs (Oncology)

Sumitomo Pharma Co., Ltd.

Job Overview

Location

Indiana, USA

Job Type

Full-time

Full Job Description

📋 Description

• Join Sumitomo Pharma America (SMPA), a global pharmaceutical company dedicated to addressing unmet patient needs across critical therapeutic areas including oncology, urology, women’s health, rare diseases, cell & gene therapies, and CNS. With a robust pipeline and marketed products, we are committed to accelerating the discovery, research, and development of novel therapies to bring them to patients faster.
• We are seeking a highly motivated and experienced Associate Director, Regulatory Affairs (Oncology) to join our dynamic Global Regulatory Affairs (GRA) team in the US. This remote position offers a unique opportunity to play a pivotal role in shaping the regulatory landscape for innovative oncology treatments.
• As a key member of the GRA team, you will primarily function as a Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned oncology products. Your expertise will be crucial in guiding these products through the complex regulatory pathways.
• You will be responsible for the meticulous preparation, coordination, and diligent monitoring of routine US and global regulatory submissions. This includes expertly crafting responses to health authority (HA) information requests, ensuring timely and accurate communication.
• This role involves actively representing GRA in project-related meetings, contributing significantly to the development of robust regulatory strategies, and providing essential regulatory input throughout the product lifecycle.
• You will operate with a moderate level of independence and autonomy, demonstrating strong problem-solving skills and the ability to navigate complex regulatory challenges. While expected to be self-directed, there will be opportunities for coaching and mentoring as you grow within the organization.
• As a Regional Regulatory Lead, you will manage critical regional regulatory activities (United States, Europe, and/or Rest of World) as an integral part of a Global Regulatory Team (GRT), ensuring alignment with global registration strategies.
• You will actively support the Global Regulatory Lead (GRL) and the CMC Regulatory Lead in formulating comprehensive regulatory strategies and managing interactions with Health Authorities.
• A key responsibility will be supporting and/or leading the documentation of regulatory authority interactions, meticulously capturing decisions and outcomes to inform future strategies.
• You will lead and coordinate project team members in developing effective strategies for applicable documents and regulatory activities, fostering a collaborative and efficient approach.
• This role requires proactive planning, coordination, authoring, and preparation of regulatory submissions. You will work closely with Regulatory Operations to ensure seamless electronic submission processes.
• Ensuring strict compliance with global regulatory requirements and adherence to internal regulatory policies and processes is paramount. You will coordinate global regulatory compliance activities, maintaining the highest standards.
• You will be responsible for providing timely and informative updates to the Global Regulatory Team, project teams, and governance boards, ensuring all stakeholders are well-informed.
• Cultivating and maintaining professional working relationships with colleagues is essential. You will foster an environment of collaboration, open communication, and idea sharing to drive collective success.
• A significant aspect of this role involves reviewing nonclinical, clinical, and CMC documentation (e.g., nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data), and contributing valuable content as needed to ensure submission readiness.
• You will proactively advise team members of potential regulatory issues, offering insightful solutions and strategic mitigation plans to navigate challenges effectively.
• Ensuring the highest quality and accuracy of all submissions to Health Authorities is a core responsibility, safeguarding the integrity of our regulatory processes.
• You will contribute to regional health authority meetings and the preparation of briefing book documentation, representing Sumitomo Pharma with expertise and professionalism.
• Assist in the development of the global regulatory functional plan by conducting thorough research, review, and interpretation of related product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support successful submissions and achieve target product labeling.
• You will be responsible for the creation and review of SOPs and regulatory department operating procedures as needed, contributing to the continuous improvement of our regulatory framework.
• This role demands a strong understanding of medical terminology and a deep knowledge of FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry.
• Experience contributing to electronic regulatory submissions and proficiency with regulatory templates are essential for success in this position.
• You will be expected to understand issues, problems, and opportunities by comparing data from different sources to draw conclusions and then choose appropriate courses of action or develop effective solutions.
• The ability to make complex decisions and a willingness to defend difficult positions with sound reasoning are critical attributes for this role.
• Comfortably presenting to all levels of the organization, including Senior Management, is a key requirement, demonstrating strong communication and leadership presence.
• Experience with oncology product development is highly preferred, leveraging your specialized knowledge to drive success in this critical therapeutic area.
• Understanding of EU Clinical Trial Regulation and other ROW country regulatory requirements related to clinical trials will be beneficial.
• This position requires a high level of initiative and independence, with the ability to exercise appropriate judgment in fast-paced, multi-demand environments. Excellent written and oral communication skills are essential, along with the ability to use a personal computer for extended periods.

🎯 Requirements

• Bachelor’s degree in a related scientific discipline.
• Minimum of 7 years of experience in the biopharmaceutical or pharmaceutical industry, with at least 4 years specifically focused in regulatory affairs.
• Demonstrated experience in oncology product development is preferred.
• Proven ability to contribute to electronic regulatory submissions and familiarity with regulatory templates.
• Strong understanding of FDA and ICH regulations/guidance documents relevant to drug development.

🏖️ Benefits

• Competitive base salary range ($156,000 - $195,000) commensurate with experience.
• Opportunity for merit-based salary increases and participation in a short-term incentive plan.
• Comprehensive health benefits package including medical, dental, and vision insurance.
• Life and disability insurance coverage.
• Generous paid time off (PTO) policy, including flexible PTO, 11 paid holidays, and an additional shutdown period.
• 80 hours of paid sick time upon hire and annually thereafter.
• Eligibility for our 401(k) plan.

Skills & Technologies

Junior

Remote

Degree Required

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Sumitomo Pharma Co., Ltd.

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About Sumitomo Pharma Co., Ltd.

Sumitomo Pharma Co., Ltd. is a Japanese pharmaceutical company engaged in the research, development, manufacture, and sale of prescription drugs, diagnostics, and over-the-counter products. Its therapeutic focus spans psychiatry, neurology, oncology, urology, cardiovascular, and metabolic disorders. Established in 1984 as Sumitomo Pharmaceuticals and headquartered in Osaka, it became a consolidated subsidiary of Sumitomo Chemical before merging with Dainippon Pharma in 2005 to create Dainippon Sumitomo Pharma. In 2022 the company rebranded to Sumitomo Pharma, continuing to leverage global R&D alliances and innovative pipelines to address unmet medical needs and improve quality of life worldwide.

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