Regulatory Operations Specialist III

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:
• Facilitate and support preparation, compilation and review of 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.
• Facilitate coordination and interaction 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, as applicable.
• Manage day-to-day operations and delivery for specific regulatory affairs engagements; oversee assigned project, including all aspects of regulatory submissions.
• Coordinate and interact with various departments like Procurement, Analytical, Technical Assurance and External manufacturers/sites, Suppliers and Distributors to understand the change, impact assessment, implementation strategy and required documentation governing the change, as applicable.
• Facilitate coordination and support for financial data management, Business plan file creation and maintenance, Supplier data management and PO creation as required.
• Facilitate coordination to create and update global labeling documents and its content and format to meet health authority requirements and client internal standards, as applicable.
• Lead stability data evaluation and report preparation, dissolution profile evaluation etc. as applicable.
• Escalate the potential issues and serve as analytical strategist and coordinator in crisis management situation, as applicable.
• Co-ordinate Data Management activities, review and submission of Import/Export Licenses, Dual Use NOC's and Import, as applicable.
• Work closely with clients to ensure client satisfaction, in transition and delivery and ensure delivery of services meets or exceeds Service Level Agreement.
• Generation of monthly status, staff member performance and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
• Resolve project-related problems within their area of expertise.
• Work closely with QA department at Fortrea to develop SOPs and training material and provide training as appropriate.
• Co-ordinate import, export licenses and qualification of analytical instruments, Change Control Management, 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.
• 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 use of consistent, efficient, and quality processes to meet timelines and deliverables according to client requirements.
• 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 7-9 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 in Packaging with minimum 6-8 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 7-9 Years of experience in the job discipline (e.g. Regulatory Affairs/Quality Assurance/Analytical science / Packaging, polymer and/or printing stream / Formulation science / material management and overall drug development and manufacturing process.
• Minimum 1+ year of experience in project management is desirable.
• Excellent command of written and spoken English and/or other languages as applicable.
• Technical proficiency with Microsoft Office suite of applications/ Document Management and publishing tools.
• Good understanding of the pharmaceutical product life cycle.
• Good review skills and concern for quality.
• Capabilities to face internal and external Audit situation.
• Good understanding of regulatory requirements, good Pharmacovigilance practices, good documentation practices and ICH-GCP guidelines desirable.

Preferred Qualifications Include:

• Bachelor's in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 7-9 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 in Packaging with minimum 7-9 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.
• Leadership, problem solving, interpersonal skills.

Physical Demands/Work Environment:

• Physical demands: Available for regional or global travel 5-10% of the time including overnight stays as necessary consistent with project needs and office location.
• Work environment: Office environment or remote.

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