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About the Role

**Job Summary:**

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Novartis Farmacéutica. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our pharmaceutical products.

Key Responsibilities:

  1. Regulatory Compliance: Ensure that all regulatory submissions, including Prescribing Information and Promotional Materials, are accurate and compliant with local regulations.
  2. Regulatory Process Management: Support the regulatory processes for product maintenance, including the creation, preparation, and submission of regulatory documents.
  3. Collaboration and Communication: Work closely with cross-functional teams, including marketing, sales, and research and development, to ensure regulatory compliance and effective communication of product information.
  4. Project Management: Manage multiple projects simultaneously, prioritizing tasks and meeting deadlines to ensure timely completion of regulatory submissions.
  5. Stakeholder Management: Develop and maintain relationships with regulatory agencies, ensuring that all interactions are professional and compliant with regulatory requirements.

Requirements:

  • Education: Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related field.
  • Experience: Minimum 2 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
  • Skills: Strong knowledge of regulatory requirements, including FDA and EU regulations. Excellent communication and project management skills.

What We Offer:

  • Competitive Salary and Benefits: We offer a competitive salary and benefits package, including health insurance, retirement plan, and paid time off.
  • Opportunities for Growth and Development: We are committed to helping our employees grow and develop their careers, with opportunities for professional development and advancement.
  • Collaborative and Dynamic Work Environment: We have a collaborative and dynamic work environment, with a team of experienced professionals who are passionate about regulatory affairs.