Regulatory affairs Jobs in Aurora, CO

Chemistry, Manufacturing and Controls Global Regulatory Affairs

The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing application, post-approval changes, and lifecycle management activities across multiple regions. Primary regions / markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing.

Job Responsibilities

Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (e.g., NDA / MAA), and post-approval lifecycle activities (supplements, renewals, variations) around small molecule drug substance, drug products, and drug-device combination products. Ensure compliance with global regulations (FDA, EMA, ICH, WHO) and anticipate regulatory changes impacting CMC requirements.

Plan, prepare, and review CMC sections of regulatory submissions (IND / IMPD / NDA / MAA, post-approval supplements). Determine regulatory CMC content and scientific / technical requirements to ensure documentation meets regulatory standards. Lead responses to Health Authority questions and deficiency letters.

Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy).

Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop CMC strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting marketed products.

Represent the company in meetings and negotiations with global Health Authorities for CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as required during late-stage product development as well as post approval changes.

Support departmental initiatives such as preparing / updating departmental job procedures. Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.

Experience in CPP application filing through eCATS, 510(j)(3) reporting through nextGen portals is a plus. Develop and maintain collaborative relationships with other local and / or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. Be proficient in the tools and systems needed for the function including and not limited to CREDO (document management), PRISM (regulatory information management system), Global Trackwise, eCTS Viewer (Viewer), Adobe Acrobat, and Microsoft Office tools. Performs other duties as assigned related to CMC RA function.

Qualifications

Education : BS / MS / PhD in Chemistry, Pharmacy, or related scientific discipline. RAC certification will be a plus.

Experience : 7+ years in Regulatory Affairs CMC, with significant experience in small molecules is required. The ideal candidate will also have some prior experience with biologic, peptide, or oligonucleotide products. Proven track record in late-stage development investigational filings, marketing applications (NDA / MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. Regulatory experience in handling-controlled substance applications will be a plus.

Skills : Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, analytical / quality control, GMP and related issues. Knowledge of CMC regulatory requirements for small molecules during late stage development, initial marketing application, and post-approval. Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational, marketed product submissions (IND / IMPD / NDA / MAA / DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. Comprehensive understanding of the global regulatory environment. Strong analytical, problem solving, organizational, and negotiation skills. Strong ability to work in a matrix environment and across cultural lines. Strong leadership, communication, and negotiation skills. Ability to manage complex projects and timelines across multiple regions. Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). CMC reviewer (assessor) with FDA or EMA will be a plus.

Competencies

Accountability for Results : Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving : Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity : Maintain an ongoing focus on the needs of our customers and / or key stakeholders.

Impactful Communication : Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration : Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development : Play an active role in professional development as a business imperative.

Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity : The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Company benefits : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com).

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