Content Specialist

2 days ago

Hyderabad, Telangana, India beBeeCMC Full time ₹ 12,00,000 - ₹ 18,00,000

Regulatory Content Specialist

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We are seeking a highly skilled Regulatory Content Specialist to join our team. This is an exciting opportunity to work on product development and maintenance of regulatory databases.

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Key Responsibilities:

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  • Maintenance of the CMC regulatory database">
  • Monitoring the evolution of the CMC regulatory landscape worldwide">
  • Analyzing changes in CMC requirements and implementing them in the database">
  • Acting as an internal expert for a set of countries">
  • Working in collaboration with external consultants">
  • Administrative tasks, research, and identification of local CMC experts">
  • Negotiation of contract terms and copyrights when needed">
  • Providing support and acting as a team representative for customers">
  • Communicating relevant information to concerned stakeholders">
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About You:

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Graduate or Postgraduate in Life Sciences with at least 1 year's experience in pharmaceutical development, CMC manufacturing, or CMC regulatory affairs.

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Desirable Qualifications:

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  • Strong knowledge of quality aspects of drug development and ICH requirements">
  • Experience on submissions, post-approval changes, responses to deficiency letters, and communications with health authorities on quality aspects of the product">
  • Knowledge of Biological entities would be appreciated">
  • Knowledge of another European language">
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About the Team:

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The Regulatory Intelligence information is part of the Life Science team responsible for daily collection, synthesis, and maintenance of data relating to regulatory information.

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Hours of Work:

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Full-time permanent role with a standard working day from 9 am to 6 pm IST and hybrid work mode.

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We are committed to equal opportunities and diversity:

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Clarivate is an equal opportunities employer. We comply with applicable laws and regulations governing non-discrimination in all locations.

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