Regulatory Operations Principal Specialist

Job Overview:

Responsible to execute risk management processes, procedures and documentation required to support quality risk management program for surgical procedures and new combination product development.

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.

• Working with company leadership to define project objectives, processes, policies, procedures and rules.

• Well versed with product knowledge.
• Participate in cross-functional meetings as needed.
• Responsible for cascading relevant information from internal and external meetings to appropriate colleagues.
• Assist with the generation, review and implementation of SOPs, Work Instructions, etc.

Qualifications (Minimum Required):

• Bachelor’s in pharmacy or related science degree (or equivalent); 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 with at least 79 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 7-9 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 1+ year experience in project management and people management is desirable.
• Industry experience of which 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.
• 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 verbal, written and presentation skills.
• Leadership capabilities.
• High degree of accuracy with attention to detail.
• Ensure client and global regulatory compliance.
• Anticipate/identify problems and takes appropriate action to correct.
• Capabilities to face internal and external Audit situation.

Preferred Qualifications Include:

• Bachelor’s in pharmacy or related science degree (or equivalent); 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 with at least 79 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 7-9 years of experience 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.
• Knowledge of data management system and pharmaceutical product life cycle will be preferred.
• 1+ 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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