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.
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.
K****nowledge, Skills, and Competencies
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.
See OPDC Competencies Chart (Level X)
P****hysical 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.
Annual Salary :
Minimum $139,184.00 - Maximum $198,990.00, 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; https://www.otsuka-us.com/careers-join-otsuka.
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.
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
At our core is perseverance, a fierce determination to overcome any obstacle regardless of setbacks, on behalf of patients and their loved ones. We place greater value on what we can achieve together than on what we can do alone because the needs of those we serve always come first. We will not be bound by doing what’s been done before. Instead, we free ourselves from preconceived notions to discover solutions that advance patient care. Our mission is clear: Otsuka-people, creating new products for better health worldwide.