Regulatory Operations Specialist II

Job Overview:

Responsible for the analytical support for the developmental projects/comparative dissolution projects and for the proper recording of information.

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.
• 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
• 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)
• 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.

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.
• Good Communication and presentation skills
• Should a team player
• Decision making capabilities
• Good Collaborative skills
• Planning and execution

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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