Regulatory Operations Expert

Job Overview:

Perform various project management and regulatory affairs activities for Fortrea clients.Manage team including performance reviews, human resource issues, and assist Senior Management in assigning resources to projects as required.Manage, coordinate and oversee the overall Regulatory Operations associated with creation/revision/compilation/approval of specifications, regulatory and labeling documents across the product lifecycle for submission by Fortrea clients to US, EU, Japan, and ROW health authorities within the agreed/stated timelines, as applicable. The post holder is responsible for supporting team members in providing this service to clients either as a support function to the client project groups or as stand-alone business.Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.

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:
• Manage day-to-day operations and delivery for specific regulatory operations engagements; oversee assigned projects, including all regulatory affairs related aspects of product life cycle maintenance.
• Facilitate co-ordination and support for preparation, compilation and review of product quality (CMC) and other regulatory documents including labeling to support product development or submissions to various countries across the world for product registrations or post approval life cycle maintenance, as applicable.
• Support in providing feedback for performance reviews of direct or indirect reportees.
• Build and develop the project team to ensure maximum performance, by providing purpose, direction, and motivation.
• Work closely with clients to ensure client satisfaction, transition and delivery and ensure delivery of services meets or exceeds Service Level Agreements.
• Analyze project status and, when necessary, revise the scope, schedule, or budget to ensure that project requirements are met.
• Report project outcomes and/or risks to the appropriate management channels and escalate issues, as necessary, according to project work plan.
• Responsible for career planning for the teams.
• Support the use and development of tools and processes; responsible for driving cost effective measures and continuous improvement in the process and operational efficiency.
• Grooming managers and talent development.
• Address complex regulatory activities in support of submissions.
• Work closely with the Quality Assurance department at Fortrea to develop SOPs and training material and provide training as appropriate to team members.
• Work closely with the project delivery team, QA manager, delivery manager and the client to define and track metrics to monitor quality and productivity for the assigned projects.
• Track domestic and international regulatory developments; attend educational workshops.
• Prepare and participate in audits, either by the client or a regulatory agency.
• Participate in cross-functional meetings as needed.
• Work collaboratively with HR to identify training and development needs and conduct workshops for individual team members.
• Consistently contributes to solving technical and/or operational problems identified by program/project members.
• Consistently proposes and executes innovative solutions which influence program/project direction.
• Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate stakeholders.
• Assist with the generation and review of SOPs, Work Instructions etc. and implementation of the same.
• Demonstrate company values on a consistent basis.

Qualifications (Minimum Required):

• Bachelor's in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) as applicable. Fortrea may consider relevant and equivalent experience in lieu of educational requirements." OR
• Bachelor's degree from Engineering /B.Tech /Packaging /Polymer /Printing stream with at least 10-13 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 10-13 years of experience 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 5+ year experience in project management and people management is desirable.
• Industry experience of which 10-13 years is relevant to Regulatory Affairs/Quality Assurance or other relevant department // Analytical science / Packaging, polymer and/or printing stream / formulation science / material management and overall drug development and manufacturing process.
• Good verbal, written and presentation skills.
• Solid leadership capabilities including attention to detail and multi-tasking skills.
• Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
• Experience in coaching project team members to strengthen their abilities and skill sets.
• Strong attention to deadlines and budgetary guidelines.
• Be able to anticipate/identify problems and takes appropriate action to correct.
• Capabilities to face internal and external Audit situation.
• Knowledge of medical and drug terminologies, medical device reporting, GxPs and worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products desirable.
• Knowledge of ICH guidelines.

Preferred Qualifications Include:

• Bachelor's in Pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) preferred with at least 10-13 years of experience in Regulatory Affairs/Quality Assurance or other relevant department. "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 at least 10-13 years of experience in Packaging field will be preferred. "Fortrea may consider relevant and equivalent experience in lieu of educational requirements."
• Knowledge of data management system, pharmaceutical product life cycle and Management Information System (MIS) will be preferred.
• Minimum 5+ year experience in project management and people management is desirable.
• Diploma or certification in Regulatory Affairs will be preferred.

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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