Regulatory Operations Principal Specialist

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:

• Responsible to provide analytical support for the developmental projects/comparative dissolution projects received from other Janssen sites.  
• Responsible to be an interface with contract laboratories, suppliers, customers and peers to define and improve project performance and expectations.
• Responsible for to coordinate with CRO and ensure that project complete with in timeline.
• Designs scientific experiments.  Actively and personally monitor lab work.  Recommends expansion or curtailment of investigations on the basis of experimental results or scientific information.
• Responsible for the preparation of test methods, technical documents, protocols and reports whenever required
• Is responsible for the proper recording of information.  Ensures that records and raw data are properly retained.  Summarizes, interprets, reviews data and draws conclusions.
• Analyzing and drawing interpretation out of the dissolution data sets.
• Trouble shooting the problems associated with instruments or methods.
• Performing activities following the GMP/ safety requirements related to the assigned activity.
• Participate in process improvement initiatives.
• Work closely with clients to ensure client satisfaction, in transition and delivery and ensure delivery of services meets or exceeds Service Level Agreements.
• Work closely with the Quality Assurance department at Fortrea to develop SOPs and training material and provide training as appropriate.
• Assist in training and mentoring of the project team.
• Implement process and productivity improvements as appropriate to improve operational efficiency.
• Prepare and participate in audits, either by the client or a regulatory agency.
• Consistently contributes to solving technical and/or operational problems identified by program/project members.
• 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.
• Is responsible for the proper recording of information.  Ensures that records and raw data are properly retained. 
• Strong analytical scientific and project management skills   • Knowledge of Regulatory Guidelines on dissolution studies e.g. FDA-SUPAC and ICH for validations and other emerging market like China, Latin America   • Hands-on experience in variety of Analytical techniques e.g. HPLC, GC, UPLC, KFT, Particle size measurement etc. and their troubleshooting.   • Good communication and presentation skills with experience of working in a regulated environment is a must.  Should be a team player   • Decision making capabilities   • Good collaborative, planning and execution skills

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 7-9 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):

• Multimedia Dissolution testing
• Knowledge of Regulatory Guidelines on dissolution studies e.g. FDA-SUPAC and ICH for validations and other emerging market like China, Latin America
• 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.
• Good Communication and presentation skills
• Should a team player
• Decision making capabilities
• Good Collaborative skills
• Planning and execution
• Knowledge of In vitro dissolution testing
• Comparative dissolution testing including multimedia dissolution
• Interface with Contract labs
• Dissolution Investigations.
• Basic knowledge on formulation (Oral solid dosage forms)
• Knowledge of Regulatory Guidelines on dissolution studies e.g. FDA-SUPAC and ICH for validations and other emerging market like China, Latin America   • Hands-on experience in variety of Analytical techniques e.g. HPLC, GC, UPLC, KFT, Particle size measurement etc. and their troubleshooting. 
• Expertise in GC-MS.

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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