Regulatory Operations Expert

4 days ago

Navi Mumbai, Maharashtra, India Fortrea Full time US$ 90,000 - US$ 1,20,000 per year
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.

  • 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 laboratories 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
  • Performing activities following the GMP/ safety requirements related to the assigned activity.
  • Key interactions areas: Drug Product development, Reg. CMC/LOC, Spec management
  • Knowledge of Regulatory Guidelines on dissolution studies e.g. FDA-SUPAC and ICH for validations and other emerging market like China, Latin America
Qualifications (Minimum Required):
  • Master's in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD ) as applicable. 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 8-10 year experience in analytical field is desirable
  • 5-7 years of relevant industrial experience in Quality assurance department in Analytical science /Formulation science / material management and overall drug development and manufacturing process

  • Good verbal, written and presentation skills

  • Solid leadership capabilities including attention to detail and multi-tasking skills

  • Ability to interact and influence with line and middle management, global counterparts, and external contacts on a functional and tactical level
  • Experience in coaching project team members to strengthen their abilities and skill sets
  • Strong attention to deadlines and budgetary guidelines
  • Be able to anticipate/identify problems and takes appropriate action to correct.
  • Capabilities to face internal and external Audit situation.
  • Knowledge of medical and drug terminologies, Medical device reporting, GxPs and worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products desirable
  • Knowledge of ICH guidelines
Preferred Qualifications Include:
  • Masters in Pharmacy or related science degree (or equivalent) preferred with more than 7-9 years of experience in formulation or Analytical development, dissolution development experience preferred . "Fortrea may consider relevant and equivalent experience in lieu of educational requirements." OR
  • Knowledge of data management system, pharmaceutical product life cycle and Management Information System (MIS) will be preferred
  • Experience in DoE, Statistical expertise is preferred
  • Diploma or certification in Regulatory Affairs will be preferred
Work Environment:
  • Work environment: Office based

Learn more about our EEO & Accommodations request here.

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