Regulatory Operations, Principal Specialist

5 days ago

Mumbai, Maharashtra, India Fortrea Full time ₹ 15,00,000 - ₹ 20,00,000 per year

Job Overview:

Responsible to provide support lab compliance activities.

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.

  • Review and approval of documents such as but not limited to protocols and report for Method qualification, method validation, transfer; methods; investigations.
  • Handling of Quality Issues, Corrective/Preventive Actions, and Change Controls related to the client as well as their contract laboratories
  • Works with the supported departments to maintain and continuously improve the quality culture to positively influence Quality KPI.
  • Actively participates to meetings with business such as Capa board, Quality improvement program and team e.g. connect meetings

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 8-10 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 8-10 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

Learn more about our EEO & Accommodations request here.

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