Regulatory Operations Specialist II

Job Overview:

Responsible for creation/revision/compilation/approval of Specifications/Documents for submission by Fortrea clients to US, EU, Japan, and ROW health authorities and oversight of the same, as applicable.

Summary of Responsibilities:

• These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally:
• Prepare, compile and review product quality (CMC) and other regulatory documents to support product development or submissions to various countries across the world for product registrations or post approval life cycle maintenance, as applicable.
• Create/revise/approve raw material and packaging specifications, and other associated documents, as applicable.
• Coordinate and interact with cross functional teams/departments for evaluation/ impact assessment of change control, review implementation strategy and required documentation governing the change and manage OOS, OOT or other product related changes, if needed.
• Support Financial data management, Business plan file creation and maintenance, Supplier data management and PO creation as required.
• Support for creation and update of global labeling documents, its content and format, QC and other associated activities for the labeling projects, as applicable.
• Support stability data evaluation and report preparation, dissolution profile evaluation etc. as applicable.
• Perform literature search and preparation of various regulatory documents in support of excipients, APIs and/or drug products, as applicable.
• Coordinate with stakeholders to understand and support import license requirements, investigation report drafting, record management and document coordination with internal and external department, as applicable.
• Responsible for specifications setting/ justification, ensuring the Quality level for Laboratory support, perform Computerized System Validation (CSV) and upgradation of existing systems/software, as applicable.
• Update and review packaging specific documents and evaluate the trigger of change on packaging documents as received from the stakeholders, as applicable.
• Manage supplier agreement process for new packaging development projects and commercial specification updates, optimize existing packaging components under the supervision of Packaging Development Engineer and/or reporting manager, as applicable.
• Assist in Global Triage meetings as required.
• Escalate the potential issues and serve as analytical strategist and coordinator across the product development stages and post approval maintenance, as applicable.
• Management, review and submission of Import/Export Licenses, Dual Use NOC’s and Import Certificates. Responsible for license applications, license availability, debiting and reconciliation, as applicable.
• Seek guidance from other team members and manager as needed and keep up to date knowledge of various regulatory guidelines required for pharmaceutical product registration and product life cycle maintenance.
• Implement the use of consistent, efficient and quality processes to meet timelines and deliverables according to regulatory requirements, standard operating procedures and maintain a culture of high customer services.
• Update and maintain internal and external (client) trackers for metrics, perform and document quality checks, as applicable.
• Assist in onboarding, training and mentoring junior staff and perform additional duties as assigned by the manager.
• Maintain training related documentation as per Fortrea and client requirements.

Qualifications (Minimum Required):

• Bachelor’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 4-7 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR
• Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification with minimum 4-7 years of experience in packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
• Speaking-English and/or other languages as applicable.

Experience (Minimum Required):

• At least 4-7 Years of experience in the job discipline (e.g. Regulatory Affairs/ Quality Assurance/Analytical science / Packaging, polymer and/or printing stream / pharmaceutics / material management and overall drug development and manufacturing process).
• Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.
• Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable.
• Good organizational and time management ability.
• Good analytical capabilities and Customer focus.
• Good review skills and concern for quality.

Preferred Qualifications Include:

• Bachelor’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 4-7 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR
• Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification with minimum 4-7 years of experience in packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
• Knowledge of Management Information System (MIS) and electronic data management system (eg: Regulatory Information Management, etc.) system will be preferred.
• Diploma or certification in Regulatory Affairs will be preferred.
• Interpersonal skills, Problem solving, Innovation and Proactive, taking ownership, Precise, Goal oriented.
• Leadership, problem solving, interpersonal skills.

Physical Demands/Work Environment:

• Physical demands: Available to travel as per business requirement.
• Work environment: Office environment or remote.

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