Associate Director, Cmc Regulatory Affairs

Job Summary

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 in compliance with global regulatory requirements and

guidance primarily US and secondarily EU for smooth and timely approvals. Ensure Otsuka’s

marketed products are in compliance with global regulatory and guidance requirements

primarily US and secondarily EU.

Job Description

Additional Responsibilities Include:

- Anticipate, develop and recommend strategies and contingency plans, provide guidance,

determine regulatory and scientific/technical requirements for CMC and GMP related

submissions and enquiries for drugs, devices and drug-device combinations from the health

authorities. .

- Prepare and/or review all CMC and GMP related documents/labels and labeling for

submission to regulatory authorities to assure compliance with regulatory standards and

scientific/technical requirements and ensure the proper preparation and approval of these

submissions

- Develop and maintain collaborative relationships with OPCJ CMC RA, Factory, Quality,

MPDD, partners, OPDC/OPEL Tech Ops, other internal groups and contract manufacturers,

packagers, suppliers etc.

- Represent Otsuka at regulatory authority CMC meetings. Lead interactions and negotiations

with regulatory authorities on CMC and GMP issues for products.

- Monitor, interpret, and provide guidance on current developments in guidances, regulations,

practices and policies in CMC and GMP areas.

- Provide regulatory assessment and input on Change Controls, review supporting data and

reports and update in computer systems as needed. Also support in-licensing due diligence

activities.

- Ensure preparation and approval of CPPs in support of Otsuka affiliates and Partners

- Be proficient in the tools and systems needed for the function including and not limited to

GEPIC (doc management), ORIOM (regulatory information), Trackwise, Accelim (invoices),

Concur (expenses), and Powerpoint

- Be proactive member of teams: Project, Clinical/Regulatory Teams (CRTs), Global Regulatory

Teams (GRTs), Submission teams and Lead CMC GRTs, and Submission CMC subteams

- Performs other duties as assigned.

Qualifications

Required

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.

- 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 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).

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

Experience:

7-9 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

Preferred

Knowledge

- Similar knowledge of EMA, Latin America and middle-east countries will be a plus

Experience

- 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.

Annual Salary :

Minimum $160,530.00 - Maximum $240,005.00, plus annual incentive: 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; .

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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