Senior Manager, CMC Regulatory Affairs (REMOTE)

Provide CMC regulatory expertise for investigational and marketed products to project teams. Establish CMC regulatory strategies for investigational and marketed products. Ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances primarily US and secondarily EU for smooth, timely approvals or continued marketing.

Position Responsibilities Include:

• Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of drug substances, drug products, devices and drug-device combination products.
• Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and enquiries.
• Independently manage preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.
• 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 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.
• Serves as the sponsor point of contact to the health authority for CMC related communications/queries.
• Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings; Serve as Otsuka CMC RA representative at Health Authority meetings, as needed.
• Monitor, interpret, and proactively assess developments in guidances, regulations, practices and policies in CMC and GMP areas.
• Provide regulatory assessment in change management.
• 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).
• Effectively manages and directs internal support staff and external consultants for assigned projects.
• Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.
• Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Trackwise, Concur (expenses), and Powerpoint.
• Performs other duties as assigned.
  
  

Qualifications

Knowledge:

• Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues.
• Thorough knowledge of FD&C Act, 21 CFR, FDA and ICH Guidances, FDA policies and practices for drugs, devices and drug-device combinations. Similar knowledge of EMA, Latin America and middle-east countries will be a plus
• 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
• Comprehensive understanding of the global regulatory environment.
  
  

Skills:

• 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 matrixed environment and across cultural lines.
• Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word,
• Excel, PowerPoint, and Outlook).
  
  

Required:

Education:

• Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. preferably majoring in Pharmaceutics or Industrial Pharmacy and minor in Medicinal Chemistry or vice-versa
• RAC certification a plus
  
  

Experience:

• 5 to 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful of investigational filings and approvals of marketing applications as the CMC Regulatory lead.
• Equivalent years of hands-on pharmaceutical product experience, such as Analytical/QC Chemistry, Formulation Science, or Product Development (including manufacturing experience) is highly desirable.
  
  

Our Benefits:

• Comprehensive medical, dental, vision and prescription drug coverage
• Company provided Basic Life, AD&D, Short-term and Long-term Disability insurance
• Tuition reimbursement
• 401(k) match
• PTO allotment each calendar year, 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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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 $143,340.00 - Maximum $204,930.00, 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 and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, 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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