Manager, Regulatory Compliance

Otsuka America Pharmaceutical Inc.; Providence (RI); Remote; USD 121,000 - 181,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Regulatory Compliance Coordinator to provide critical support for GRA activities from planning through execution, aligning with the Global Regulatory Compliance Lead and collaborating with cross-functional teams.

You will help maintain SOPs, support inspection readiness, and own regulatory impact assessment tracking, while ensuring timely updates to GSOP systems and coordination of monthly regulatory milestone reporting.

Qualifications

• 4+ years of general regulatory affairs experience and knowledge of the drug development process.
• 3 years audit and inspection experience.

Responsibilities

• Function as SOP Coordinator supporting GRA-related document revisions and GSOP systems.
• Lead inspection readiness activities including managing inspection calendars and CAPA tracking.
• Collaborate with Regulatory Intelligence and Pharmacovigilance to identify and confirm annual RRS updates.
• Develop and implement compliance newsletters and communications strategies.
• Coordinate monthly updates for regulatory milestone reports with Regulatory Strategy.
• Support coordination of GRA meetings and maintain GRA portals and contact lists.
• Analyze compliance metrics and provide monthly KPI reports to leadership.

Skills

Regulatory affairs experience

Audit and inspection experience

Education

Bachelor's degree in life sciences, scientific, or engineering field

Job description

Remote

Full time

R13190

Job Summary

• Provides critical support for regulatory compliance activities from planning to execution in alignment with the Global Regulatory Compliance Lead and working closely with cross-functional areas of the company.

• Provides strategic support for SOP maintenance and GxP compliance.

• Supports GRA inspection and audit readiness and management activities.

• Owns regulatory impact assessment compliance and tracking.

Job Description

• Function as SOP Coordinator supporting all GRA-related controlled document revisions cycles and ad-hoc revisions, work with the GSOP office to schedule KOM, manage timelines, follow up and support GRA key stakeholders with document revisions, maintain knowledge and access to GSOP systems (i.e., Veeva Vault, Monday.com), maintain the GRA SOP revision tracker, participate in quarterly GSOP engagement meetings, act as GRA representative for DEAL reviews

• Lead inspection readiness activities including but not limited to management of inspection calendar, supporting development of functional area slide presentations, scheduling KOMs, communicating audit/inspection notifications to the team, support pre-document requests, reviewing final audit reports, tracking CAPAs and Deviations

• Collaborate with Regulatory Intelligence and Pharmacovigilance to identify and confirm annual RRS updates

• Participates in review and qualification of PV dashboard curated inbox notifications

• Develop and implement the distribution of newsletters and compliance communications strategies to enhance organizational awareness and adherence to regulatory requirements

• Coordinate and facilitate monthly updates for regulatory milestone reports in partnership with Regulatory Strategy

• Support coordination and facilitation of GRA meetings such as the full staff meeting, SGRT, GRA departmental face-to-face meetings etc.

• Maintain updates to GRA Collaboration Portal, identify outdated materials, and manage quarterly update with key stakeholders to ensure accuracy of information posted

• Maintain updates to GRA contact list, Outlook GRA distribution lists, and departmental organizational charts

• Analyze compliance metrics and trends, provide recommendations along with monthly reports for key performance indicators such as training and post on the GRA Collaboration Portal to leadership, and drive corrective actions as needed

• Prepare and maintain compliance functional area work instructions such as SOP revisions, GRA milestone review, onboarding/offboarding materials

• Provide meeting support for cross functional meetings within GRA including development of project reports, presentation materials, meeting agenda, meeting minutes, identify outcomes and follow through on all deliverables.

• Ensure plans and activities are implemented in accordance with timelines and escalate any challenges or deviations for resolution in a timely manner

• Create, administer, and summarize surveys as needed

Qualifications/ Required

Knowledge/ Experience and Skills:

• Bachelor's degree in life sciences, scientific, or engineering field.

• 4+ years of general regulatory affairs experience and knowledge of the drug development process is required.

• 3 years audit and inspection experience.

Preferred Qualifications

• Prior experience working in the pharmaceutical and/or healthcare industry.

• Prior experience with new prescription drug/biologic applications (IND and/or NDA/BLA).

• Strong oral and written communication skills.

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

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

• Proactively manages and communicates issues, scopes, progress and risks throughout the project lifecycle ensuring key stakeholders are informed.

• Able to prioritize and work well in a fast-paced environment to multi-task, problem solve and support the Global Regulatory Leaders.

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

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

• Able to consider and offer innovative solutions to problem solving.

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 $121,103.00 - Maximum $181,125.00, 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

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.

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.