Senior Manager, CMC Global Regulatory Affairs

Otsuka Pharmaceutical Co.; United States; Remote; USD 146,000 - 211,000; Full time

Job summary

Join a forward-thinking company as a CMC Regulatory Lead, where you will play a pivotal role in ensuring compliance with global regulatory standards for innovative drug products. This position involves developing strategies for biologic and small molecule drugs, preparing regulatory submissions, and collaborating with cross-functional teams to optimize processes. Your expertise will contribute to timely approvals and the ongoing success of our products in the market. If you are passionate about regulatory affairs and thrive in a dynamic environment, this opportunity is perfect for you.

Benefits

Comprehensive medical coverage

Dental and vision insurance

Tuition reimbursement

401(k) match

Flexible time off

Paid holidays

Short-term and long-term disability insurance

Student loan assistance

Qualifications

• 7+ years of CMC regulatory experience in the pharmaceutical industry.
• Comprehensive knowledge of drug development and regulatory requirements.
• Proficient in preparing regulatory submissions for FDA and equivalent.

Responsibilities

• Develop and execute regulatory strategies for drug products.
• Prepare and review CMC-related documents for regulatory submissions.
• Independently manage INDs, BLAs, and amendments within timelines.

Skills

Regulatory Strategy Development

CMC Regulatory Knowledge

Analytical Skills

Problem Solving

Communication Skills

Collaboration

Technical Document Preparation

Project Management

Education

Bachelor in Pharmaceutical Sciences

Masters in Pharmaceutics

Ph.D. in Biochemistry

Tools

CREDO

ORIOM

Trackwise

Microsoft Office Suite

Job description

Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka’s products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing.

Job Description

• Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug-device combination products.
• Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and inquiries.
• Represents CMC RA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with global regulatory lead(s).
• Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements.
• Develop and execute regulatory strategies for post approval changes for marketed products and communicate with respective cross-functional teams. Providing regulatory strategies on CMC changes for development phase products.
• Prepare departmental job procedures.
• Experience in CPP application filing through eCATS, 510(j)(3) reporting through nextGen portals is a plus.
• Interact with manufacturing and quality groups, partner organizations, regarding CMC issues.
• Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and reports within company timelines and in accordance with regulations and guidelines.
• Develop and maintain collaborative relationships with other local and/or global functional units [OPCJ CMC RA, Factory, Quality, MPDD, OPDC/OPEL Tech Ops] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc.
• Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings.
• Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.
• Independently handle monthly meetings with global cross-functional teams for assigned products.
• Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Trackwise, TRS Viewer, Concur (expenses), and Microsoft office tools.
• Performs other duties as assigned.

Qualifications/ Required:

Knowledge/ Experience and Skills:

• Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues.
• Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products.
• Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canda
• Comprehensive understanding of the global regulatory environment.
• Proactive strategic thinker
• Operationally minded (know how to prepare a high quality technical document or submission using internal systems)
• Strong analytical, problem solving, organizational and negotiation skills.
• Strong collaborative inter-personal, communication, presentation and meeting leading skills.
• Strong ability to work in a matrix environment and across cultural lines.
• Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• 7-years CMC regulatory experience in the pharmaceutical industry with a history of successful investigational filings and approvals of marketing applications as the CMC Regulatory lead
• Regulatory experience in handling controlled substance applications will be a plus

Educational Requirements:

• Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology
• RAC certification a plus

Preferred:

• Similar knowledge of EMA, Latin America and middle east countries will be a plus
• 3 - 5 years of hands-on pharmaceutical product development, including scale-up and technology transfer to manufacturing and/or manufacturing experience is highly desirable.
• As a CMC reviewer (assessor) with FDA or EMA is highly desirable.

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 $210,100.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. 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, f lexible time off , paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka .

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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 .

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