Regulatory Operations Specialist II

Job Overview:

Summary of Responsibilities:

• Work with the team to execute risk management processes, procedures and documentation required to support quality risk management program. Focus will be on combination products that could be used in surgical procedures so an understanding of surgical procedures will be helpful
• Providing quality oversight to new combination product development as well as lifecycle management.
• Deliver technical reports fully in compliance with cGMP's
• Collaborate and build trusting relationships with all stakeholders and business partners in identifying opportunities for improvement and meeting goals and objectives (This will need calls/meeting in US time)
• Collaborate on data driven risk assessments (risk identification, analysis and evaluation) and formulate risk mitigation plans as well as support Corrective and Preventive Action (CAPA) plan initiatives.
• Executing the functions as called out in Standard Operating Procedures.
• Coordination of documents in the document management system.
• Be accountable to assure quality & compliance with procedures and customer requirements.
• Identify potential issues, perform trouble shooting, resolve conflicts and provide solutions for technical documentation related activities, coordinate the issues in a timely manner.
• 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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