Regulatory Affairs Coordinator

1 day ago

Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time US$ 40,000 - US$ 80,000

Job Description:

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The Regulatory Affairs Coordinator plays a crucial role in ensuring compliance with regulatory requirements for assigned projects. The role involves the collation, compilation, and timely dispatch of required regulatory documentation to affiliates/customers and follow-up on timely submission of applications to the health authority.

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Responsibilities:

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  • Collate, compile, and dispatch regulatory documentation in accordance with established systems, processes, and procedures.">
  • Maintain accurate records in global regulatory databases, update trackers, and status sheets.">
  • Respond to queries from affiliates/customers and health regulatory agencies regarding regulatory submissions.">
  • Support tender projects by coordinating compilation of submissions and database updates.">
  • Act as a backup for team members and assist with other projects as assigned.">
  • Complete assigned trainings in a timely manner.">
  • Contribute to creating an environment of teamwork, empowerment, and mutual trust.">
  • Work collaboratively to achieve outcomes while maintaining a safe working environment.">
  • Demonstrate behaviors that align with organizational values: Collaboration, Courage, Perseverance, and Passion.">
  • Adhere to compliance programs, including Global Business Ethics and Compliance Program, Quality policies, Safety, and HR policies.">
  • Perform other duties as assigned.">
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Requirements:

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To be successful in this role, candidates should possess:

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  • A strong academic background in Pharmacy or a related field.">
  • Excellent communication, organizational, and analytical skills.">
  • Knowledge of regulatory affairs principles, particularly New Product Dossier and PLCM submission requirements.">
  • 0-1 years of experience in regulatory affairs, preferably in international markets.">
  • Able to work effectively in a team-oriented environment.">
  • Willingness to learn and adapt to changing regulations and processes.">
"]",

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