Regulatory Affairs Specialist

3 semanas atrás


Santo Amaro, Bahia, Brasil Novartis Tempo inteiro
Job Title: Regulatory Affairs Analyst

About the Role:

The Regulatory Affairs Analyst will play a crucial role in ensuring compliance with regulatory requirements for post-approval changes in products within the organization. This position involves collaborating with cross-functional teams to prepare and submit required documentation to HA, while ensuring adherence to relevant guidelines and legislations.

Key Responsibilities:

  • Prepare and submit post-approval changes (CMC variations) to HA, including dossier review and strategy definition.
  • Conduct regulatory evaluation of post-approval changes to assess their impact and ensure adherence to relevant guidelines and legislations.
  • Collaborate with cross-functional teams to define project timelines and provide information on regulatory requirements for submissions.
  • Review less complex post-approval change dossiers.
  • Maintain and update area databases, ensuring all information and documentation is accurate and up-to-date.
  • Support in reviewing and updating labeling material and ensuring compliance with HA requirements.
  • Participate in meetings with minor and moderate impact at trade associations.
  • Provide regulatory guidance and support to cross-functional teams during the development and implementation of post-approval changes.

Requirements:

  • Bachelor's degree in Pharmacy or related courses.
  • Prior experience working in the regulatory affairs area of Pharmaceutical Industry.
  • Detail-oriented and highly organized, capable of managing multiple projects simultaneously.
  • Advanced English language proficiency.

What We Offer:

  • Competitive salary, annual bonus, pension scheme, life insurance, 30 days annual leave, year-end recess, hybrid work model (home office 2x a week), flexible working arrangements, birthday day-off, maternity and paternity leave, subsidized dining facilities, health and dental insurance, employee recognition scheme, free parking lot (Santo Amaro and Cambe), Gympass, Space Energized for Life, gym (Santo Amaro) and virtual self-development tools.

Join Novartis and be part of a team that is shaping the future of healthcare.



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