Regulatory Affairs Specialist

Há 2 dias

São Paulo, São Paulo, Brasil beBeeregulatory Tempo inteiro R$64.000 - R$97.000
Regulatory Affairs Specialist

We are seeking a skilled Regulatory Affairs Specialist to support regional Chemistry, Manufacturing and Control (CMC) strategy, the preparation of documentation, and the execution of regional post-approval submissions and new product registrations.


Main Responsibilities:
  • Assess regulatory change control by identifying requirements for submissions.
  • Track submissions and approvals, ensuring bidirectional communication of status with local regulatory colleagues and global teams.
  • Review documentation to support submissions according to local and regional requirements.
  • Assist in timely responses to Health Authority queries, ensuring compliance with local and regional regulatory requirements.
  • Attend cross-functional meetings, providing input on local and regional requirements and maintaining close communication with local regulatory colleagues and global teams.
  • Support product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.
  • Provide input on continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practices.
  • Stay informed about local and regional regulatory policy trends while maintaining the regulatory intelligence repository for regional markets.

Required Skills and Qualifications:
  • Bachelor's degree in life sciences, chemistry, pharmacy, or a related field.
  • Advanced English skills - reading, writing and speaking.
  • Previous experience in the area of Chemistry, Manufacturing and Control (CMC) Regulatory Affairs;
  • Strong teamwork skills and the ability to communicate effectively with various stakeholders.
  • Familiarity with product registration processes and lifecycle management.
  • Availability to work in a hybrid model in São Paulo/SP.

Benefits:
  • Opportunity to work in a dynamic environment.
  • Chance to develop skills in Regulatory Affairs.
  • Collaborative team environment.

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