Regulatory Affairs Specialist

4 semanas atrás

São Paulo, São Paulo, Brasil Gilead Sciences Farmaceutica do Brasil Ltda Tempo inteiro

Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences Farmaceutica do Brasil Ltda. This is an exciting opportunity for an experienced regulatory professional to contribute to the development and execution of robust regulatory strategies while ensuring regulatory compliance.

Key Responsibilities

  • Support the definition, setting, and oversight of regulatory strategies to maximize regulatory success towards achievement of program objectives, in conjunction with local, regional, and global teams.
  • Provide strategic and tactical advice to achieve timely and efficient regulatory submissions, including Advanced Therapy Medicinal Products (ATMP) applications and life cycle maintenance submission, while ensuring compliance with applicable regulatory requirements and internal policies and standards.
  • Lead regulatory submissions for new ATMP applications and life cycle maintenance.
  • Engage with the broader Regulatory community within Gilead.
  • Contribute to cross-functional initiatives representing the regulatory function and interacting with a diverse number of stakeholders both internal and externally.
  • Support clinical development programs as a member of a global cross-functional team.
  • Complete or otherwise provide support in the preparation of routine regulatory submissions for commercial or investigational products in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, regional requirements, and scientific and company policies and procedures.
  • Perform document filing and retrieval functions in accordance with departmental standard operating procedures (SOPs).
  • Perform workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to others as needed.
  • With guidance, may participate in the development of routine labeling changes and drug listings.
  • Contribute to process improvements and/or other special projects within Regulatory Affairs.
  • Helps expedite and improve regulatory administrative activities by training and advising new or less experienced colleagues.
  • Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

Requirements

  • BSc or MSc in a life sciences or related field with significant regulatory experience (minimum 6 years) in the pharmaceutical/biotechnology industry in Brazil.
  • Experience in cell therapy will be an advantage.
  • Extensive knowledge of regulatory requirements in biologicals (highly desirable in the field of cell therapy) and in managing close interactions with HA.
  • Experience in developing complex regulatory strategies and leading regulatory submissions.
  • Demonstrates strong analytical and critical thinking skills, attention-to-detail, strong communication and writing skills, and project management skills.
  • Experience working in project teams, being capable of effectively interact with internal and external parties to information gather and drive projects through to completion to tight timelines.
  • Motivated and works independently with limited direction from a senior Regulatory Affairs professional.

Skills and Behaviors

  • Excellent verbal and written English communication skills, including relevant technical/ATMP language skills.
  • Excellent interpersonal skills are required to work cross-functionally on local and global assignments.
  • Excellent planning and organizational skills with the ability to work simultaneously on multiple projects with tight timelines.
  • Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.
  • Planning and information seeking skills and ability to work on specific tasks with some supervision.
  • Problem-solving, strategic thinking skills with ability to impact and influence.
  • Attention to detail with accuracy and quality.
  • Ability to understand and effectively engage with external and internal stakeholders.
  • Self-motivator, enthusiastic, tenacious, and energizing.
  • Proactive and open to share, advise, and educate colleagues across the organization.

Gilead Core Values

  • Integrity (Doing What's Right)
  • Inclusion (Encouraging Diversity)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)

Leadership Commitments

  • I AM BOLD in aspiration and AGILE in execution.
  • I CARE and make time for people.
  • I LISTEN, speak openly, and explain the 'why.'
  • I TRUST others and myself to make sound decisions.
  • I OWN the impact of my words and actions.

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