Regulatory Innovation Associate

4 weeks ago

hyderabad, India Lifelancer Full time

About the job

The Regulatory Innovation Associate plays a critical role in the development of regulatory services technology products to drive innovation and differentiation.

Under general supervision, provides regulatory expertise and technical support for regulatory technology innovation initiatives.

Essential Functions:

  • Navigate through the Health authority (HA) websites and drug compendiums to procure multiple sets regulatory information based on the product development needs;
  • Classify the regulatory data based on the scenarios to be evaluated;
  • Perform through Quality Check (QC) of the digitized regulatory information/data;
  • May perform manual comparisons between two or more documents or labels or document or label data sets to clearly demarcate the textual and contextual differences, highlight the medical and scientific keywords as per the agreed legends;
  • Through Quality Check (QC) of system generated comparison outputs to identify and record the observations/undesired outcomes;
  • Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content;
  • Segregate, clarify and record all observations in systems like Application Lifecycle Management (ALM);
  • Understand the business use case to author and execute User Acceptance Testing (UAT);
  • Coordinate and liaise between Subject Matter Experts (SME) and Information Technology (IT) experts to execute and enhance the system functionalities;
  • Provide input on interpretation and implementation of key regional regulations, guidelines, and best practices;
  • Contribute to RADDS technology and continuous improvement initiatives;
  • Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters;
  • May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person;
  • May prepare and deliver trainings, as appropriate;
  • Performs other tasks or assignments, as delegated by Regulatory management;
  • Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;

Preferred Skills:

Understanding of global and country specific regulatory requirements across multiple regulatory activities such as MAAs, MATs, CMC, variations, etc.;

Skilled In analyzing Medical and Scientific content in the Prescription and Patent Labels;

Knowledge of global standards and regulations related to Registrations and Life cycle maintenance of Bio-pharmaceutical products;

Qualifications

  • Bachelor's Degree Degree in Lifescience or related discipline Req;
  • Problem-solving ability with the ability to analyze risk and make appropriate recommendations/decisions;
  • Well-versed with IT tools and processes. (i.e., IT tools like ALM, MS Excel, etc.);
  • Minimum 2 years of pharmaceutical industry experience., inclusive of at least 1 year of regulatory and/or related experience;
  • Good understanding of the Research and Development process (Chemistry, Manufacturing Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
  • Good interpersonal communication (oral and written) and organization skills;
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients;
  • Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
  • Demonstrates self-motivation and enthusiasm;
  • Ability to work on several projects, with direction from senior staff as appropriate;
  • Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
  • Ability to make decisions on discrete tasks under senior supervision.

Please use the below link for job application and quicker response.

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