Regulatory Operations Specialist III

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):

• Bachelors in pharmacy or related science degree (or equivalent); or 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
• Bachelors degree from Engineering / /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 6-8 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 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.
• Minimum 1 year of experience in project management is desirable.
• Excellent command of written and spoken English and/or other languages as applicable.
• Technical proficiency with Microsoft Office suite of applications/ Document Management and publishing tools.
• GMP experience
• Working skills in computer applications including Word Excel
• Quality mindset
• Open for change and improvement
• Ability to meet deadlines
• Detail-oriented with commitment to high level of data integrity and accuracy
• Able to work independently
• Good understanding of the pharmaceutical product life cycle.
• Good review skills and concern for quality.
• Capabilities to face internal and external Audit situation.
• Good understanding of regulatory requirements good Pharmacovigilance practices good documentation practices and ICH-GCP guidelines desirable.
• Good Communication and presentation skills
• Should a team player
• Decision making capabilities
• Good Collaborative skills
• Planning and execution

Preferred Qualifications Include:

• Bachelors in pharmacy or related science degree (or equivalent); or 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
• Bachelors degree from Engineering / /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 7-9 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.
• Leadership problem solving interpersonal skills.

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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