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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