[Hiring] Lead, RA CMC Small Molecules (Director) @Astellas Pharma

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com. This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope:We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy.This role will lead the development and execution of innovative regulatory strategies for small molecule products (primarily) and biologics or other new modalities (secondary) across all phases of development and commercialization. The ideal candidate will be a recognized thought leader who can influence regulatory policy, drive strategic initiatives, and represent the company in key external forums. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions.Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for new products), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders. Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders.Leads and/or coaches a team or individual team member of regulatory CMC professionals. The ideal candidate brings deep expertise in designing and executing innovative, accelerated CMC regulatory strategies across oncology and rare disease portfolios. This includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that enable faster patient access while ensuring robust quality, compliance, and lifecycle readiness.Success in this role requires strong strategic acumen, cross-functional leadership, and a proven ability to partner with health authorities to shape regulatory solutions that support program acceleration and long-term product sustainability. Responsibilities and Accountabilities:Strategic Leadership:• Define and implement global CMC regulatory strategies with a strong focus on North American requirements. • Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major markets including Japan, China, and EU.Policy & Advocacy:• Represent the company in industry associations, ICH working groups, and industry forums to influence regulatory policy and harmonization efforts. • Monitor evolving regulatory landscapes in the US and other global countries, translating changes into actionable strategies for internal teams. Cross-Functional Collaboration:• Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment on CMC strategies. • Serve as a scientific and regulatory resource for complex technical issues, enabling science and risk-based solutions.External Engagement:• Build and maintain strong relationships with FDA, PhRMA, ICH, other regulatory authorities and industry collaborations. • Lead advocacy initiatives for innovative technologies and precedent-setting projects. Operational Excellence:• Oversee preparation and review of CMC sections for regulatory submissions (IND, NDA, BLA, post-approval changes). • Ensure consistency and quality in dossier preparation across regions. Expected Key Accountabilities from Global Regulatory Aspects• Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy.Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions. • Member of global teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders. • Provides CMC regulatory expertise for New Product Planning and Licensing including during due diligence activities.• Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders.• Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and marketing authorization registration filings and DMFs. • Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects.• Provides regulatory guidance for compendial issues (Ph.Eur., USP and JP etc.) and monograph preparation. • Provides support to the CMC RA Modality Head to develop an environment to enable CMC RA professionals to optimally operate in the matrix environment of RA, R&D, Product Development & Manufacturing within Astellas. • Leads and/or coach a small team or individual team member of (regulatory) CMC professionals, provides training. • Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas.Established rapport with global health authorities that enables constructive exploratory discussions. • Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications for operations, revenue, and/or credibility. QualificationsRequired• Advanced degree in Chemistry, Engineering or equivalent degree (PhD, PharmD, MS preferred). • 10+ years of direct experience in CMC Regulatory Affairs within the pharmaceutical or biotech industry, with significant exposure to North American regulatory requirements.• Proven track record in developing and implementing global CMC strategies and influencing regulatory policy. • Strong knowledge of FDA, ICH and global guidelines; prior experience in ICH initiatives highly desirable. • Expert technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and an in-depth knowledge of global regulatory CMC submission requirements, with a strong understanding of the application of ICH and other guidance. • Exceptional communication and leadership skills; ability to influence internal and external stakeholders.• Experience representing companies in trade associations and industry forums. • Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope. • Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral• dosage forms) is required. • Demonstrated track record for successful interactions with global health authorities related to CMC submissions.• Ability to navigate a global organization and to act globally and regionally as appropriate. • Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders in high impact situations. • Proven leadership skills is preferred. Salary Range$170,450 - $267,850 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)Benefits:• Medical, Dental and Vision Insurance• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down• 401(k) match and annual company contribution• Company paid life insurance• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions• Long Term Incentive Plan for eligible positions• Company fleet vehicle for eligible positions• Referral bonus program#LI-SS Apply tot his job