Senior Manager, Global Regulatory Affairs

Otsuka America Pharmaceutical Inc.; Cheyenne (WY); Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Health benefits

401(k) match

Paid time off

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a regulatory affairs professional to support global regulatory strategy, planning, and execution of submissions for investigational and marketed prescription drugs.

You will manage lifecycle activities, assess regulatory challenges, and coordinate with the GRL and cross-functional teams to ensure timely, compliant submissions. The role requires experience with global submissions (IND/CTA/NDA/BLA/MAA), strong communication skills, and the ability to

Qualifications

• Bachelor's degree with 5+ years’ experience or Master’s with 2 years’ experience in regulatory affairs or related areas in pharma/healthcare.
• Experience with global regulatory submissions (IND, CTA, NDA/BLA, MAA) submissions.
• RAC certification a plus, knowledge of FDA/ICH regulations.

Responsibilities

• Develop global regulatory strategy and plans for orphan/regulated products.
• Coordinate submissions and responses to health authorities (INDs, CTAs, NDAs) within timelines.
• Provide regulatory guidance to cross-functional teams and GRL.
• Lead and coordinate internal/external resources for project deliverables.
• Ensure accuracy and compliance of submission documents and oversight of sponsor interactions with authorities.

Skills

Regulatory strategy

Regulatory intelligence

Leadership

Written communication

Office tools

EDMS

Education

Bachelor's degree in regulatory affairs/related field

Master's degree in regulatory affairs/related field

Tools

EDMS

Regulatory submissions software

MS Office

Job description

Remote

Full time

R12320

Position Summary

Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.

Job Responsibilities

• Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).


• Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.


• Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.


• Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.


• Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.


• Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.


• Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.


• Serves as the sponsor point of contact to the health authority.


• Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues.


• Effectively manages and directs internal support staff and external consultants for assigned projects.


• Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions.


• Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output.


• Assess and develop innovative ideas to move GRA department to address current and future challenges.

Knowledge, Skills, and Competencies

Knowledge

• Experience working in the pharmaceutical and/or healthcare industry.


• Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).


• RAC certification a plus.

Skills

• Strong oral and written communication skills.


• Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.


• Able to successfully interpret and apply regulatory intelligence to work output.


• Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed.


• Able to establish close communications and working relationship with cross functional teams to meet business objectives.

Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow.

• Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS).

Competencies

See OPDC Competencies Chart (Level X)

Physical Demands and Work Environment

Travel (approximately 20%)

See document Physical Demands and Work environment for further requirements.

Education and Related Experience

Bachelor's degree with 5+ years’ experience or Master’s degree with 2 years’ experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions 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 $150,034.00 - Maximum $224,250.00, 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.

Application Deadline

This will be posted for a minimum of 5 business days.

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.

Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112 .

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Stay connected with Otsuka by joining our Talent Community. Tell us about your interests, and we’ll notify you about future opportunities that align with your background. https://community.hireez.com/cielo-otsuka/82cb3591

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 [e-mail] .

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.