Senior Manager, CTA Regulatory Strategy - Remote

The Sr. Manager, CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of global investigational submissions and manages lifecycle regulatory activities for assigned Clinical Trial Application projects in alignment with the Global Regulatory Lead (GRL).

• As an integral member of Otsuka's Regulatory Operations team, provides support for regulatory strategy assignments, monitoring, and oversight, as well as a lead or support of GRA efforts
• Ensures assigned projects are completed with quality, on-time, and within established budgets
• Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA-CMC, etc.) to contribute to global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations
• Acts as primary liaison between Regulatory Operations and Clinical Management as well as other multiple company stakeholders to coordinate clinical trial application activities, primarily within the European Union (EU), United Kingdom (UK), and other regions as required
• Engages with affiliates and collaborators to plan, submit, and gain authorization for clinical trial applications to Health Authorities
• Research and apply regulatory intelligence and knowledge of strategic options to effect innovative regulatory pathways and solutions to complex global requirements and regulatory challenges.
• Serves as the primary contact to Health Authorities (HA) within EU, UK, and other regions as required
• Designs and implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvement
• Collaborates with alliance partners to achieve corporate objectives for shared dossier development, submission, and archival activities
• Supervises staff to assure quality control checks of deliverables intended for submission to regulatory agencies and compliance with electronic regulatory standards
• Oversees project team members for assigned clinical trial application deliverables, including work assignments to vendor partners
• Ensure that Regulatory Activities are performed at high quality and compliant to local regulatory requirements
• Provides leadership and guidance for Process Mapping Teams (e.g., Key stakeholder for Regulatory Submissions, Key stakeholder for Clinical Trial Application Regulatory Notifications)
• Develops and maintains assigned work instructions
• Establishes and builds collaborative relationships with colleagues
• Maintains current awareness of the EU, UK, and other applicable local regulatory requirements, updates colleagues as appropriate, and provides necessary guidance to other departments / function

Qualifications Required:

• Overall knowledge of regulation/guidance in support of EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019
• Adept in professional and clear communication when interacting with regulatory authorities
• Experience in global pharmaceutical development and lifecycle management including clinical development, marketing authorization application preparation and submission, regulatory support to commercialization and management of post-authorization issues
• Ability to provide strategic input for key submission documents
• Ability to communicate and negotiate effectively with internal/external individual organizations, especially regulatory authorities
• Expert knowledge of Document Management Systems (Documentum preferred)
• Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint
• Knowledge in developing processes across multiple departments/divisions that leverage technology
• Recent experience with Clinical Trial Applications for EU and UK is essential, start-up activities is a plus
• Minimum of 7 years of regulatory strategy experience and in-depth first-hand experience with application electronic submissions within CTIS and IRAS and other Health Authority portals

Preferred:

• Demonstrated performance in managing and producing quality time-intensive deliverables
• Strong influencing skills and experience with outsourcing
• Strong staff management skills
• Proven ability to solve complex issues through innovative problem solving
• Well defined written and oral communication skills
• Knowledge how/when to apply organizational policy or procedures to a variety of situations
• Demonstrated flexibility in dealing with change and diversity
• Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment
• Successful engagement in multiple initiatives simultaneously
• Certification (such as Regulatory Affairs Professionals Society (RAPS))
• Prior project management experience

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 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 $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, 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://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. 

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.

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. 

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