Regulatory Affairs Professional

6 days ago

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

Regulatory Affairs Specialist

  • The role involves the compilation, submission and management of regulatory documentation for assigned projects.
  • Responsibilities include maintaining accurate database records pertaining to products, in line with established systems and processes.
  • Supporting and coordinating regulatory affairs projects, as assigned, including tender projects.

Key Responsibilities:

  • Collation, compilation and timely dispatch of required regulatory documentation to affiliates/customers and follow-up on timely submission of applications to health authorities.
  • Effective communication and follow-up with departments for compilation of tender submissions and database updates.
  • Responding to queries received from affiliates/customers and health regulatory agencies on regulatory submissions.
  • Maintaining accurate records in global regulatory databases, updating established trackers & status sheets and ensuring accuracy of information.
  • Adhering to assigned responsibilities, acting as a back-up for team members and supporting other projects as assigned.
  • Completion of all assigned trainings in a timely manner.
  • Contribution towards creating and promoting an environment of teamwork and empowerment built on mutual trust and respect.
  • Working in a safe manner, collaborating as a team member to achieve all outcomes.
  • Demonstrating behaviors that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion.
  • Ensuring personal adherence to compliance programs including Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • All other relevant duties as assigned.

Education & Qualifications:

  • A Graduate/Postgraduate in Pharmacy.

Skills & Abilities:

  • Good academic background. Knowledge about New Product Dossier and PLCM submission requirements will be an additional advantage.

Experience:

  • 0-1 years of regulatory affairs experience in international markets.

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