Associate Director, Regulatory Affairs

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director, Regulatory Affairs CMC. The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she is expected to provide regulatory CMC support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio.

This position has a moderate-high level of autonomy with some coaching and mentoring.

Key Responsibilities

• Lead the planning and preparation of standalone CMC submissions and response to health authority (HA) inquiries.

• Define submission strategies and content; identify regulatory approval risks and propose mitigation plans. Provide authoring support as needed.

• Reviews CMC components of relevant documents and contribute to content development as appropriate.

• Represent Regulatory CMC in cross-functional meetings and collaborate with internal and external stakeholders on assigned projects.

• Partner with Quality and other functions to assess the regulatory impact of proposed changes to clinical materials and commercial products.

• Support the review of CMC reports, cGMP documents as part of global regulatory submissions packages.

• Stay current with international and domestic regulatory requirements and best practices. Provide guidance on interpreting and implementing regulations, guidelines, company procedures, and working practices.

• Collaborate with Regulatory Operations to ensure submissions meet agreed timelines and established standards.

• Keep line management and key stakeholders updated on developments that may affect submission timelines or HA approvals.

• Foster a collaborative and professional working environment that promotes idea sharing and teamwork.

• Contribute to process improvements through cross-functional initiatives related to CMC submissions.

Key Core Competencies

• Unquestionable ethics, professional integrity, and personal values consistent with SMPA values. 

• Strong written, verbal, and interpersonal communication skills.

• Ability to thrive in a diverse and dynamic environment; adaptable to changing priorities and work effectively in a matrix organization.

• Experience managing and compiling Module 3 documentation.

• Expertise in CMC lifecycle management for drug substance and drug product, including support for process development, analytical testing, and scale-up for registrations.

• Solid understanding of US, EU, and Canada regulations, guidelines and regulatory processes for development and lifecycle maintenance.

• Experience working within Veeva RIM system is preferred.

Education and Experience

• BS or MS in a scientific field (e.g. Chemistry or Biology); advanced degree preferred.

• 8 – 12 years or 6 – 8 years (with MS degree) of relevant experience in biotech or pharmaceutical industry, with specific experience in regulatory CMC.

• Prior experience in lifecycle management within regulatory.

The base salary range for this role is $156,000 to $195,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.