Regulatory Operations Principal Specialist

Job Overview:

Responsible to provide analytical support for the developmental projects/comparative dissolution projects received from other client sites.

Summary of Responsibilities:

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally.

• Responsible to provide analytical support for the developmental projects/comparative dissolution projects received from other client 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 method
• Performing activities following the GMP/ safety requirements related to the assigned activity.
• 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)

Qualifications (Minimum Required):

• Bachelor's in Pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or Masters) as applicable. Fortrea may consider relevant and equivalent experience in lieu of educational requirements."
• Speaking-English at ILR level 3+ or higher)
• Writing/Reading- (English at ILR level 4 or higher)
• Leadership, problem solving, interpersonal skills.

Experience (Minimum Required): 

• At least 7-8 years of experience in Regulatory Affairs/Quality Assurance/ /Analytical science / 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
• Technical proficiency with Microsoft Office suite of applications/ Document Management and publishing tools
• Good understanding of the pharmaceutical product life cycle
• Good organizational and time management ability
• Excellent interpersonal skills
• Good analytical capabilities and Customer focus
• Good review skills and concern for quality
• Scientific or Clinical research experience desirable
• Capabilities to face internal and external Audit situation.
• Good understanding of regulatory requirements, GxP and ICH guidelines.
• Experience in regulatory document formatting and ensuring publishing readiness of documents, regulatory affairs, regulatory operations, regulatory publishing.

Preferred Qualifications Include:

• Bachelor's in Pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or Masters) with at least 7-8 years of relevant experience/ Analytical science / Formulation science / material management and overall drug development and manufacturing process
• Knowledge of data management system, pharmaceutical product life cycle.
• Diploma or certification in Regulatory Affairs.
• Leadership, problem solving, interpersonal skills.

Work Environment:

• Work environment: Office environment

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